Recall Z-1193-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Philips Heartstart FRx automated external defibrillator (AED), Model 861304
| Date | Mar 23, 2010 (initiated Nov 2, 2009) |
| Status | Terminated |
| Reason | Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09. |
| Quantity | 92 units distributed domestically, 452 units distributed internationally |
| Distribution | Worldwide Distribution. |
| 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 |