Recall Z-0432-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
| Date | Nov 22, 2010 (initiated Aug 7, 2008) |
| Status | Terminated |
| Reason | The affected device may not deliver appropriate defibrillation therapy. |
| Root cause | Employee error |
| Action | Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008. |
| Quantity | 1 unit |
| Distribution | Nationwide Distribution: to one account in Arkansas. |
| 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 |