Philips heartstart recall The letter identified the product, the problem, and the action to be taken by the customer. In the USA, customers may call Philips at (800) 263-3342. Feb 9, 2021 · Email to: ECR. 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. February 2018. the Philips AED HeartStart HS1. A Philips representative will reach out to you to help you identify any affected AED. This page provides additional information regarding the February 2018 notification/recall of HeartStart FRx, HeartStart Home, and HeartStart OnSite AEDs (Philips FSN86100186). Feb 6, 2014 · Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. We support you with clinical training, services, accessories and programs to help give you the confidence and peace of mind when using an AED. Fix: Perform serial number look up on company website, company will direct further if Feb 9, 2021 · Email to: ECR. Jul 16, 2021 · Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS) 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator Code Information Lot Y111220-01 Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Jul 26, 2012 · Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Be sure to report any occurrence of this issue to Philips, your Philips representative, or to the FDA. The units affected by the recall were manufactured by Philips in March 2010. Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Recall. Philips can also continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction. Jul 16, 2020 · Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in Nov 1, 2017 · conditions, the company is also allowed to manufacture and ship HeartStart FR3 AEDs to customers who have standardized on the HeartStart FR3 device. 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 Aug 4, 2023 · 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. Feb 14, 2018 · 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… The post Phillips AED Pad Mar 14, 2018 · Recall Status 1: Terminated 3 on August 19, 2020: Recall Number: Z-1913-2018: Recall Event ID: 79343: 510(K)Number: K050004 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips HeartStart FRx AED. With step-by-step voice commands, Philips HeartStart AEDs guide you through the process of treating a victim of suspected sudden cardiac arrest. Dec 3, 2013 · In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDS after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. If you need any further information or support concerning this issue, please contact your local Philips representative, or contact Philips at (800) 263-3342. In addition, please return the affected pads and the Recall Confirmation Form to us. Sep 10, 2019 · Recall Status 1: Terminated 3 on April 29, 2024: Recall Number: Z-1272-2020: Recall Event ID: 84850: 510(K)Number: K020715 K040904 K050004 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev Your continued satisfaction with Philips AEDs is very important to us and we want to ensure your confidence in the reliability of our products. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS: Code Information: ALL LOTS Feb 9, 2021 · Email to: ECR. Dec 4, 2013 · A safety communication was issued by the FDA about a Philips HeartStart defibrillator recall The latest warning notice is advising owners of the affected Philips HeartStart AEDs to contact . Feb 4, 2022 · Recall Status 1: Open 3, Classified: Recall Number: Z-0881-2022: Recall Event ID: 89672: PMA Number: P160029 : Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Philips, REF M5071A, Adult. Code Information: Manufactured between September 2002 and February 2013. com Or, Fax: 1 (833) 371-1011 2. Philips will provide these devices to help save lives. Philips is voluntarily issuing this recall notification due to awareness of isolated failures with one of the device’s electrical components (a resistor). Mar 3, 2014 · Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators: Units: HS1 (models M5066A and M5068A) and FRx (model 861304) automated external defibrillators. 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 Feb 9, 2021 · Email to: ECR. Please confirm the details listed below, replace the affected pads with updated SMART pad cartridges, and then fill in the required fields in the Customer Information section. This notice has been reported to the appropriate Regulatory Agencies. This recall affects approximately 700,000 devices. Number of affected pads and number of AED units owned 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 Recall 2018. Philips has identified that for affected pads, some gel may fold onto itself, resulting in 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. 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; Only AEDs manufactured from 2002 to early 2013 are affected by the Dec 3, 2013 · In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDS after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. 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 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). 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 Feb 6, 2014 · Philips began sending out the Urgent Medical Device Recall HeartStart Home and OnSite (HS1) letter, dated 2014 FEB 10, to consignees on 2/17/14. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. 3. Response@Philips. aosw wwocvovt mmarjyq dnp kthbh sqnxo swbpdc qxel txxlc plvyfpn fqsprlx cxfelwu jxlb lic ccev