Philips heartstart recall. Identification number.
Philips heartstart recall Philips HeartStart FRx AED Accessory Kit. Class 2 Device Recall Philips HeartStart: Date Initiated by Firm: June 05, 2015: Date Posted: August 04, 2015: Recall Status 1: Terminated 3 on February 25, 2019: Recall Number: Z-2328-2015: Recall Event ID: 71584: 510(K)Number: K110825 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Recall Status 1: Terminated 3 on February 15, 2017: Recall Number: Z-1317-2010: Recall Event ID: 54892: 510(K)Number: K051134 : Product Classification: Defibrillator Monitor - Product Code MKJ: Product: HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14. Designed for the ordinary person in the extraordinary moment, Philips HeartStart HS1 AED is ready to act and virtually ready to go. Type II. HeartStart Home and OnSite (HS1) Recall The recall affects only the Philips HeartStart OnSite, HS1, FRx and Home Defibrillator AEDs; The Philips HeartStart FR, Forerunner, FR2 and FR2+ AEDs are not affected, but these devices are old and should be replaced with newer life-saving devices like the OnSite model; Philips HeartStart HS1 defibrillator acts as your personal coach to guide you through the process of treating a victim of suspected sudden cardiac arrest. In Description: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be AED serial number lookup. 3000 Minuteman Rd Andover MA 01810-1032: For Additional Information Contact: Debbie Levasseur 978-659-4065: Manufacturer Reason for Recall: Email to: ECR. Skip to main content Site notifications. It should click into place and the green PULL handle should be down. Philips Healthcare - 2/4 - FSN86100195B November, 2018 URGENT – Medical Device Recall Certain Philips HeartStart MRx M3538A Batteries May Fail to Function AFFECTED PRODUCTS Product: M3538A Lithium-Ion Batteries for the HeartStart MRx Monitor/Defibrillator. 02. Subscribe. Please visit the AED serial number lookup. Philips - HeartStart FR3 Defibrillator , The HeartStart FR3 is Philips best professional-grade AED with advanced features for the professional respon. Pre-connected SMART Pads II can be used both for adults and children. Specific Class 2 Device Recall Philips Healthcare HeartStart MRx: Date Initiated by Firm: August 26, 2016: Create Date: September 19, 2016: Recall Status 1: Terminated 3 on July 24, 2020: Recall Number: Z-2842-2016: Recall Event ID: 75041: 510(K)Number: K031187 K040404 K051134 K061707 K062233 : PHILIPS Emergency Care and Resuscitation-1/4- FSN86100213A 2020 APR 01 URGENT — Medical Device Recall HeartStart XL Defibrillator/Monitor (Model number M4735A) Rotary therapy selector switch may fail Dear Valued HeartStart XL Customer, Philips has identified that the HeartStart XL Defibrillator/Monitor (Model number M4735A) rotary therapy Philips HeartStart FR3 AED Class 2 Recall. Mit dieser On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. This Field Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart Onsite automated external defibrillators (AEDs) in order to meet public health needs globally. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Consumables and accessories Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission Recall start date: October 19, 2023. For any additional questions/information, Philips discovered that certain M3538A Lithium-Ion Batteries manufactured between December 28, 2017 and March 20th, 2018 for the HeartStart MRx monitor/defibrillator may fail to charge A problem has been detected in the Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) that, if it were to occur, could pose a risk for patients. And the chances of survival decrease for each minute that passes without CPR and a shock from an AED [2]. The device may fail to function should water intrusion occur. About the Recall: Clear overview of recall and products affected Voluntarily “Urgent Medical Device Correction” for the M5071A Adult and M5072A Infant/Child Pads Cartridge for use with HS1/Onsite/Home AEDs. 03. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided. m. Designed with you in mind, HeartStart Home is easy to set up and includes automatic CPR guidance features like voice prompts and CPR guidance to help guide you step-by-step through the treatment of sudden cardiac arrest. com Or, Fax: 1 (833) 371-1011 2. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). The Philips HeartStart Home Defibrillator (M5068A) was designed to be safe, reliable and easy to use. 017: Code Information On February 16, 2018, Philips Healthcare issued a recall notification after discovering certain Philips Heartstart AED(s) (automated external defibrillator(s) in their portfolio has an electrical component (a resistor) that was prone to failure. Not applicable Philips Medical Systems. in Eindhoven, the Netherlands. 8-Volt Lithium Ion Battery (ModeI M3538A). We will unpack details for each recall. We are Here! Monday - Friday, 7am - 6pm CST. Recall Date: 02/14/2018 Title: HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Recall Units: Onsite (A13A-xxxxx or A13B-xxxxx) and Frx Automated External Defibrillators (B04L-xxxxx through B13B-xxxxx) Issue: Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. Which AED pads does it affect: This recall affects only the Philips Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART URGENT – Medical Device Recall Certain Philips HeartStart MRx M3538A Batteries May Fail to Function Dear Customer, Philips discovered that certain M3538A Lithium-Ion Batteries manufactured between December 28, 2017 and March 20th, 2018 for the HeartStart MRx monitor/defibrillator may fail to charge or to provide Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission Recall start date: October 19, 2023. Philips HeartStart FR3 AED Accessory Kit. Class 2 Device Recall Philips HeartStart MRx Monitor/Defibrillator: Date Initiated by Firm: February 04, 2014: Date Posted: February 26, 2014: Recall Status 1: Terminated 3 on September 03, 2020: Recall Number: Z-1110-2014: Recall Event ID: 67427: 510(K)Number: K051134 : Product Classification: The Philips FR2 / FR2 + AEs should be replaced immediately and you can contact AED One-Stop Shop for a quote at 855-677-2337 or Sales@AEDOneStopShop. 4. Lift out the used cartridge. ) / voluntary recall notification (U. If you own a Heartstart Onsite AED or Onsite Home AED you may be eligible for replacement Adult Electrode Pads. The Philips HeartStart OnSite, HS1, Home, and FRx AEDs should be checked for recalls by sharing your AED serial number with an AED One-Stop Shop consultant. The Philips HeartStart Home Defibrillator is the first defibrillator available without a prescription. Philips intends to honor orders, as inventory allows, until February 2, 2022. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices For questions about Philips Healthcare products in the US please contact: Professional Healthcare Product Suppor Including on-site maintenance and parts ordering for existing products To replace your HeartStart pads, locate the latch at the top edge of the AED and slide it to the side to release the pads cartridge. FREE SHIPPING on online orders of $99+* 800-544-0048. Philips is issuing a Field Safety Notice regarding the Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1, Automated External Defibrillator (AED) devices. AED FAQs. In addition to notifying consignees that may have been omitted from notification This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Skip to Main Content. Status: Ongoing: Mandated? Recalling Firm: Philips North America LLC: Initial Notification : Letter: Similar To: HeartStart Event Review suite of software products, without taking your FR2+ out of service. Voluntary Field Safety Notice Information Philips Respironics Sleep and Respiratory Care devices. Class 2 Device Recall Philips HeartStart MRx Monitor/Defibrillator: Date Initiated by Firm: April 10, 2013: Date Posted: December 31, 2013: Recall Status 1: Terminated 3 on April 13, 2017: Recall Number: Z-0613-2014: Recall Event ID: 67035: 510(K)Number: K051134 : Product Classification: Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; If you need help with your HeartStart FR2 AED, you’ve come to the right place. Recall. HeartStart HS1 . 2. Philips HeartStart FRx Defibrillator Product information Bright_DataSheet1. Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A: Code Information: Software Versions A. FAQs. There is a possibility that a faulty internal electrical component may cause the devices to fail to administer shocks to Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. The affected device list is the Philips HeartStart FRx, Philips Heartstart OnSite, and Philips Home AEDs produced between 2002 and 2013 Philips Management No. Receive notifications for new and updated recalls and alerts by category. You can learn more on Philips’ website. This page provides additional information regarding the February 2018 notification/recall of This letter will fully explain the purpose of the recall including all details of any actions you will need to take, if any at all, pertaining to one or more of the Philips HeartStart AEDs you have purchased in the past. November 16, 2021. only). Free Shipping. Remove a new SMART Pads Cartridge from its package and insert into the cartridge well. On all online orders over $99. es wurde ein Problem mit den automatisierten externen Defibrillatoren (AEDs) HeartStart HS1 von Philips festgestellt, das bei Auftreten eine Gefahr für Patienten bedeuten kann. Heartstart Defibrillation Pads. February 2022. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient. Get reviews, manuals, pricing, specs, package information, pads, batteries and more, all in one place! FREE SHIPPING on online orders of $99+* 800-544-0048. The foundations of Philips were laid in 1891 when Anton and Gerard Philips established Philips & Co. 2-13-37 Konan, Minato-ku, Tokyo 108-8507 Notification Regarding the Voluntary Recall of Infant/Child SMART Pad Cartridges for the Philips HeartStart HS1 AED Thank you very much for your continued support. As announced in Field Safety Notice (QSR22-023/2021-CC-EC-012), it has been confirmed that the gel Recall Status 1: Terminated 3 on April 29, 2021: Recall Number: Z-2549-2019: Recall Event ID: 83681: 510(K)Number: K020715 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758: Code Information Class 2 Device Recall HeartStart FR3 Defibrillator: Date Initiated by Firm: October 10, 2018: Create Date: October 18, 2018: P160028 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 Field Safety Notice. Field Safety Notice. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Diagnostic and clinical informatics AED serial number lookup. Built to perform and backed by Philips A five-year warranty and limited product indemnity comes with every HeartStart Defibrillator. Emergency Care and Resuscitation-2/2- FSN86100130 2014 FEB 10 . Philips AED AED Accessory Kits. I understand . Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Consumables and accessories AED serial number lookup. Media Gallery; Philips makes no representations or warranties of any kind with regard to any third-party websites or the HeartStart FRx . Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices › Title: HeartStart MRx Defibrillators Recall Units: Model/Item numbers: M3535A, M3536A Issue: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device’s Gas Discharge Tube. 04. Recalling Firm. Connect with Philips. qxd 2/24/05 6:46 PM Page 1. Add To Cart. Back. Get notified. Smart PADS 04/06/2022 Philips North America LLC Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A: 2 10/08/2021 Philips North America LLC Philips, HeartStart HS1 OnSite Defibrillator , Model #'s Source of recall: Health Canada Issue: Medical Devices Audience: General Public, Healthcare Professionals, Hospitals A problem has been identified in certain philips m5072a heartstart infant/child smart pads cartridges (lot y111220-01) which are used with the philips heartstart onsite and heartstart home automated If you own a Heartstart Onsite AED or Onsite Home AED you may be eligible for replacement Adult Electrode Pads. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Diagnostic and clinical informatics HeartStart HS1 . The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. 2 Sudden cardiac arrest can h anyone, a Bright_DataSheet1. Dear HeartStart AED Owner, We are contacting you because our records show you are the owner of one or more Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. The letter identified the product, the problem, and the action to be taken by the customer. Created 10/18/2018 FDA Link Recalling Firm/ Manufacturer: Philips Medical Systems, Inc. Philips has updated the US recall notification to align with the FDA’s recommendation in connection with Reason. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Careers . Philips makes no representations or warranties of any kind with regard to any third-party A sudden cardiac arrest (SCA) can happen anywhere at any time [1]. TheHeartStart HS1 AED provides real-time guidance through simple, step-by Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; If you need help with your HeartStart FR2 AED, you’ve come to the right place. Philips Healthcare . Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. Philips HeartStart FRx AED Refresh Pack-AED Refresh Packs Question: Is it time to replace your pads & battery? AED electrode pads and batteries ha. Automated external defibrillators may not fully meet IPx5 water ingress specification. Philips North America LLC Recall 88637 Information. To replace your HeartStart pads, locate the latch at the top edge of the AED and slide it to the side to release the pads cartridge. AED serial number lookup. If the Infant/Child SMART Pads Cartridge is still inside the pouch, then it can remain in service until replaced. com. Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; If you need help with your HeartStart FR2 AED, you’ve come to the right place. Report a health or safety concern The Philips HeartStart FRx defibrillator features intuitive step-by-step voice instructions, including CPR guidance, and an audible metronome to help guide basic life support (BLS) responders while treating a suspected sudden cardiac arrest (SCA). Class 2 Device Recall Philips HeartStart MRx Monitor/Defibrillators: Date Initiated by Firm: April 27, 2020: Create Date: May 28, 2020: Recall Status 1: Terminated 3 on July 19, 2021: Recall Number: Z-2157-2020: Recall Event ID: AED serial number lookup. Email to: ECR. Philips HeartStart AEDs - Product defect correction - gel separation from the foam/tin backing when peeled from the yellow plastic liner. Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Diagnostic and clinical informatics The voluntary recall of HeartStart AEDs made between 2005 and 2012 by Philips Healthcare was issued late last year and is ongoing. Account details; In 2002 After this date, Philips will no longer be able to ship HeartStart MRx pad electrodes and batteries in the USA. URGENT – FIELD SAFETY NOTICE . Please confirm the details listed below, replace Recall Initiation Date: 20210209: Recalling Firm: Philips North America LLC: Initial Notification : Letter: Similar To: GE Healthcare, LLC Recall 88959 Osteomed, LLC Recall 88990 Greiner Bio-One North America, Inc. Shop AED Class 3 Device Recall Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304. Our HeartStart OnSite AED Remote Monitoring Suite completely redefines the concept of managing AEDs. Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Recall Status 1: Terminated 3 on April 29, 2024: Recall Number: Z-1271-2020: Recall Event ID: 84850: 510(K)Number: K020715 K040904 K050004 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips HeartStart FRx AED, Model 861304, FRx codeRev: E. Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in customer's possession may have been omitted from one or more previous recalls or customer information notifications. Мы хотели бы показать здесь описание, но сайт, который вы просматриваете, этого не позволяет. Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. United Recall class. The Philips HeartStart FRx defibrillator features intuitive, step-by-step voice instructions, including CPR guidance, and an audible metronome to help guide basic life support (BLS) responders while treating a suspected sudden cardiac arrest (SCA). conditions, the On 10 January 2023, Philips expanded their Product Defection Correction for the HeartStart AEDs. Continue. If you have any questions about this product, please call the Philips AED (HS1) Pad Recall Office at 0120-143-079 (weekdays 9:00 a. Shop the Philips HeartStart OnSite AED at AED Superstore. PHILIPS Emergency Care and Resuscitation Page 1 of 4 F5N86100229A 04 Feb 2021 URGENT-Safety Notification HeartStart HS1 Home, HS1 Onsite, FRx and FR2/FR2+ Devices may have been omitted from previous recalls Dear Customer, Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in your Philips - HeartStart MRx Defibrillator , Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. With its ease-of-use and real-time, step-by-step voice prompts the Philips HeartStart FRx automated external defibrillator (AED) is designed to help ordinary people as they respond in an extraordinary Royal Philips veröffentlicht heute eine Sicherheitsmitteilung für bestimmte Philips BiPAP-, CPAP- und mechanische Beatmungsgeräte, um identifizierte potenzielle Gesundheitsrisiken im Zusammenhang mit der schalldämpfenden Schaumstoffkomponente auf Polyesterbasis (PE-PUR) zu adressieren. Designed with you in mind, HeartStart Home is easy to set up and includes automatic CPR guidance features like voice prompts and CPR guidance to help guide you Need help or customer support with Philips AEDs? Get user guides, technical documents and how-to videos. In addition to notifying consignees that may have been omitted from notification What is the recall: Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in your possession may have been omitted from one or more previous recalls. This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Professional healthcare. TGA Recall Reference: RC-2020-RN-00365-1: Product Name/Description: Philips HeartStart XL Defibrillator/Monitor Model number M4735A ARTG 95661 (Philips Electronics Australia Ltd Defibrillator, manual) Recall Action Level: Hospital: Recall Action Classification: Class I: Recall Action Commencement Date: Philips Japan, Ltd. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Consumables and accessories Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Which AED pads does it affect: This recall affects only the Philips Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child HeartStart HS1 . Products. If you are looking for help with your Philips HeartStart HS1/Onsite or Home product, you've come to the right place. According to the FDA, Philips Healthcare issued an Urgent Medical Device Correction notification/Field AED serial number lookup. HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices . This recall is being conducted due to the possibility of a Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; Carrying case for HeartStart MRx, includes 3 accessory pouches, shoulder strap and sleeve. Following Philips’ public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice* in June 2021, Philips Respironics Philips HeartStart FRx; Philips HeartStart OnSite; Philips HeartStart Home; If you are the owner of 1 or more Philips AEDs (manufactured between September 2002 and February 2013), you may have received this letter (this past March 2018), indicating a Voluntary Medical Device Recall Notice directly from Philips regarding your AED. Philips Medical Systems. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U. M5071A Adult Pads Recall Confirmation Form Dear customer, We will provide updated SMART pad cartridges to replace affected SMART pad cartridges for the Philips AED HeartStart HS1. to 5:30 p. An extended two- for Recall: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use FDA Determined Cause 2: Software design: Action: Philips Healthcare sent an Urgent Medical Device Recall letter dated January 2013 on January 28, 2013. If your The Recalling Firm or distributors will contact customers to arrange for replacement and removal of affected devices. Additional information. Philips makes no representations or warranties of any kind with regard to any third-party websites or the AED serial number lookup. HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs . We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday Class 2 Device Recall Philips Heartstart HS1 Home: Date Initiated by Firm: April 30, 2010: Date Posted: June 28, 2010: Recall Status 1: Terminated 3 on December 10, 2012: Recall Number: Z-1917-2010: Recall Event ID: 55579: 510(K)Number: K020715 K040904 : Product Classification: What is the recall: Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1/OnSite/Home AEDs. My Account TGA Recall Reference: RC-2021-RN-00538-1: Product Name/Description: Philips HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED ARTG 92346 (Philips Electronics Australia Ltd Defibrillator - Non-rechargeable semi-automatic external defibrillator) Recall Need help or customer support for Philips Intrepid defibrillator or monitor? Watch how-to videos, get user guides, or download technical documents. Issue: Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. One recall relates to the device’s potential to fail to start HeartStart Event Review suite of software products, without taking your FR2+ out of service. You are about to visit a Philips global content page. RA-64007. 00 or lower and B. Education & Training. Philips intends Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Under certain. My Account (0) Cart. HeartStart FRx . Philips HeartStart FR3 AED Class 2 Recall. HeartStart Onsite Document downloads and links. Philips makes no representations or warranties of any kind with regard to any third-party By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. This recall Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. A recall has has been issued for the Philips M5071A (adult) and M5072A (infant/child) AED pads. “The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected Philips issued an Emergency Medical Device Correction regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) Consumer products; Professional healthcare; About us. This contamination could prevent an adequate connection between the pads cartridge and the AED. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices › Class 2 Device Recall Philips HeartStart MRx Monitor/Defribillator: Date Initiated by Firm: February 18, 2014: Date Posted: February 26, 2014: Recall Status 1: Terminated 3 on February 20, 2018: Recall Number: Z-1118-2014: Recall Event ID: 67487: 510(K)Number: K051134 : Product Classification: Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Secure Payment. Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; Education & Training . Response@Philips. A smart service to ensure your AED is ready to use. Klikk her for viktig informasjon om sikkerhetvarselet angående enkelte CPAP, BiPAP og ventilatorer fra Philips Respironics. FR2 Document downloads and links. Report a health or safety concern. S. Recall 88563 Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices . URGENT – Medical Device Recall Certain Philips HeartStart MRx M3538A Batteries May Fail to Function Dear Customer, Philips discovered that certain M3538A Lithium-Ion Batteries manufactured between December 28, 2017 and March 20th, 2018 for the HeartStart MRx monitor/defibrillator may fail to charge or to provide AED serial number lookup. The Philips is issuing a Field Safety Notice regarding the Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1, Automated External Defibrillator (AED) devices. Philips HeartStart Home, and Heartstart OnSite AEDs Class 2 Recall. • The likelihood of successful Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Date Initiated by Firm: August 07, 2008: Date Posted: November 22, 2010: Recall Status 1: Terminated 3 on December 01, 2010: Recall Number: Z-0432-2011: Recall Event ID: 49384: URGENT - Medical Device Recall Philips HeartStart MRx Monitor/Defibrillator Page 1 of 4 Philips Healthcare FSN86100121B May 2013 Therapeutic Care UPDATED - Device May Fail to Deliver Defibrillation Therapy Dear Customer, This Field Safety Notice SUPERCEDES Field Safety Notice, FSN86100121A, issued in April 2013. PROBLEM DESCRIPTION Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in your possession may be among By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. The Philips HeartStart FRx defibrillator features intuitive, step-by-step voice instructions, including CPR guidance, and an audible metronome to help guide basic life support (BLS) responders while treating a suspected sudden cardiac arrest (SCA) Pre-connected SMART Pads II can be used for both adults and children. A123456000 M 1 For use by Philips - Company name - Person in charge To: Philips Japan, Ltd. 22100 Bothell Everett Highway, Bothell, Washington. FRx Document downloads and links. An extended two- As part of the Philips Emergency Care Informatics Suite and specifically developed to work with the Philips HeartStart Intrepid monitor/defibrillator, the Device Readiness application is designed to give you the peace of mind that comes with knowing AED serial number lookup. What is the recall: Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1/OnSite/Home AEDs. Best of all, neither maintenance nor service contracts are required to maintain indemnification benefits. Report Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Philips is voluntarily issuing this recall notification due to awareness of isolated failures with one of the device’s electrical components (a resistor). This site uses cookies. A safety communication was issued by the FDA about a Philips HeartStart defibrillator recall on December 3, even though the devices were removed from the market more than a year ago. Recall class. Although the likelihood of this problem Register your device(s) on Philips' recall website or call 1-877-907-7508 to provide additional information to help prioritize replacement of your device and to get updated Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. AED Machines. Consequently, Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart Infant/Child defibrillator pads contain incorrect labeling. Details. 22100 Bothell Everett Highway, Bothell, Washington Industry. Specific products(s) numbers/models that are affected: M5071A Adult and M5072A Infant/Child Pads Cartridge for use with HS1/Onsite/Home AEDs. Philips is TGA Recall Reference: RC-2020-RN-00365-1: Product Name/Description: Philips HeartStart XL Defibrillator/Monitor Model number M4735A ARTG 95661 (Philips Electronics Australia Ltd Defibrillator, manual) Recall Action Level: Hospital: Recall Action Classification: Class I: Recall Action Commencement Date: HeartStart FRx . The HeartStart HS1 AEDs are intended for use in public places or the home. It allows anyone with little or no training to treat the most common cause of suspected sudden cardiac arrest (SCA) by delivering a shock quickly and effectively, wherever SCA happens. Important update to Philips US recall notification. Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. Shop AEDSuperstore. Not applicable. My Account HeartStart HS1 . The company begun. Please visit the Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A: Code Information: Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517 Recalling Firm/ Manufacturer: Philips North America LLC 22100 Bothell Everett Hwy Bothell WA awareness resulting from the recall notification/field safety notice* and is predominantly observed in the US. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices For questions about Philips Healthcare products in the US please contact: Professional Healthcare Product Suppor Recall Status 1: Terminated 3 on September 05, 2013: Recall Number: Z-0483-2011: Recall Event ID: 56816: 510(K)Number: K003565 K013425 : Product Classification: automatic external defibrillator - Product Code MKJ: Product: HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. Toggle A recall has been issued for Heart Sync, Multi-function Defibrillation Electrodes because they The Philips HeartStart FRx defibrillator features intuitive, step-by-step voice instructions, including CPR guidance, and an audible metronome to help guide basic life support (BLS) responders while treating a suspected sudden cardiac arrest (SCA) Pre-connected SMART Pads II can be used for both adults and children. PHILIPS COMPANY STATEMENT 2022 Recall. While waiting to receive the replacement, customers should keep the Infant/Child SMART Pads Cartridge Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information HeartStart HS1 . Contact & support. Shop with confidence. As announced in Field Safety Notice (QSR22-023/2021-CC-EC-012), it has been confirmed that the gel Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. 3000 Minuteman Rd Andover MA 01810-1032: For Additional Information Contact: 978-687-1501: Manufacturer Reason for Recall: HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling: FDA Philips recently announced that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). Philips makes no representations or warranties of any kind with regard to any third-party websites or the information Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The Recalling Firm/ Manufacturer: Philips Medical Systems, Inc. Read More » February 9, 2018 Phillips / Class 2 Device Recall Philips HeartStart MRx: Date Initiated by Firm: June 20, 2012: Date Posted: June 27, 2012: Recall Status 1: Terminated 3 on March 16, 2017: Recall Number: Z-1896-2012: Recall Event ID: 62333: 510(K)Number: K051134 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Philips AED Recall Check Free Shipping On orders over $99; Contact Us: 855-200-7320. 2-13-37 Konan, Minato-ku, Tokyo 108-8507 Notification Regarding the Voluntary Recall of Adult SMART Pad Cartridges for the Philips HeartStart HS1 AED Thank you very much for your continued support. Due to this situation, Onsite AEDs are not available. qxd 2/24/05 6:46 PM Page 2 • The current national survival rate for SCA is less than five percent. Like other pieces of essential safety equipment, the Philips HeartStart Home Defibrillator was designed to be safe, reliable and easy to use. The HS1 AED Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Follow the procedure described on the Return Procedure Form to return all SMART pad cartridges to us for recall as confirmed in Step 9, along with the Recall Confirmation Form. As announced in Field Safety Notice (QSR22-023/2021-CC-EC-012), it has been confirmed that the gel Philips, or your Philips Distributor, will supply a replacement of all M5072A Infant/Child SMART Pads Cartridges from Lot Number Y111220-01. Medical Device Recall/Notification. Home AEDs All Class 2 Device Recall Philips Healthcare HeartStart MRx: Date Initiated by Firm: August 26, 2016: Create Date: September 19, 2016: Recall Status 1: Terminated 3 on July 24, 2020: Recall Number: Z-2842-2016: Recall Event ID: 75041: 510(K)Number: K031187 K040404 K051134 K061707 K062233 : About the Recall: Clear overview of recall and products affected Voluntarily “Urgent Medical Device Correction” for the M5071A Adult and M5072A Infant/Child Pads Cartridge for use with HS1/Onsite/Home AEDs. Emergency Care and Resuscitation Page 2 of 4 FSN86100229A March 2021 Created with TMPL0227, Revision A AFFECTED PRODUCTS Philips HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be for Recall: Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices › Alerts, recalls and safety information: Philips: HeartStart FR2+ AED, HeartStart FRx AED, HS1 (Onsite) AED, HS1 (Home) AED; RaySearch: Radiation Therapy Treatment Planning System; News and Updates > Important update to Philips US recall notification. HeartStart Home and OnSite (HS1) Recall The recall affects devices manufactured between May 2007 and January 2008, with model numbers M3860A and M3861A, distributed by Philips, and M3840A and M3841A, distributed by Laerdal Medical. Philips Japan, Ltd. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Diese Seite enthält zusätzliche Informationen hinsichtlich der Benachrichtigung/Rückrufaktion vom Februar 2018, die die AED-Geräte HeartStart FRx, HeartStart Home und HeartStart OnSite (Philips This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). SIGN IN / SIGN UP. Account. FDA Recall Posting Date. Due to customer feedback and complaints, Philips is notifying additional customers who problem has been detected in the Philips HeartStart XL+ Defibrillator/Monitor that, if it were to occur, could pose a risk for patients. ). News center . Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Units Affected subject to this Recall: A total of 1,880 Lithium-Ion Batteries Email to: ECR. RRP $2,399 Designed for the ordinary person in the extraordinary moment, Philips HeartStart HS1 AED is ready to act and virtually ready to go. On July 26, 2021, The Philips HeartStart MRx Monitor/Defibrillator could fail to deliver defibrillation therapy in the Manual Defib, Sync Cardioversion, or AED modes. The last day to place orders for MRx pad electrodes, batteries and accessories will be January 2, 2022. This Field Safety Notice is intended to inform you about: On February 16, 2018, Philips Healthcare issued a recall notification after discovering certain Philips Heartstart AED(s) (automated external defibrillator(s) in their portfolio has an electrical Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. Warranty Information . Products HeartStart Home or HeartStart OnSite recall, click here for more information. Recall notification ; Customer Services Portal ; Document Library ; Publications ; Press contacts ; If you need help with your Philips HeartStart FRx AED, you’ve come to the right place. 00 and lower: Recalling Firm/ Manufacturer: Philips Medical Systems 3000 Minuteman Road Andover MA 01810-1032: For Additional Information Contact: 978-659-1500: Manufacturer Reason. Identification number. Philips has issued two separate recalls for its HeartStart XL+ defibrillator/monitor which may delay therapy and endanger patients. After this date, Philips will no longer be able to ship HeartStart MRx pad electrodes and batteries in the USA. Find similar products. A Philips representative will reach out to you to help you identify any affected AED. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information The FDA has classified the recall of over 47,000 Philips HeartStart MRx Monitor/Defibrillators as a Class I recall. RA-72333. AED frequently asked questions. 0330 043 5818. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. Advanced Molecular Imaging ; Computed Tomography Machines & Solutions ; Diagnostic and clinical informatics Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. 3. 10. Deals of the Week Sign up now! 0 Toggle navigation. oyq clyf miij wrjn aeriz dsgn nkd gptdhzw jgmfyi cqyme