Recall Z-0308-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
HeartStart FR2+ Defibrillator
| Date | Dec 27, 2006 (initiated Dec 19, 2006) |
| Status | Terminated |
| Reason | Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation |
| Root cause | Process design |
| Action | On 12/19/06 the firm sent letters via return receipt to all domestic customers. The letter advised customers of the issue and if the user encounters the problem, to press the button again with additional force. The users are to contact Philips for replacement. The devices can be used until the user receives a replacement. |
| Quantity | 2000 units |
| Distribution | Distribution is worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A Agilent Technologies, Inc., Dec 20, 2000 |