Recall Z-0642-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems North America Co. Phillips
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART
| Date | Jan 4, 2013 (initiated Jul 26, 2012) |
| Status | Terminated |
| Reason | 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. Philips had determined there is a need to emphasize the importance o |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6). |
| Quantity | 201,598 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050004 | PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 Philips Medical Systems, Feb 25, 2005 |