Recall Z-0546-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 500 automated external defibrillator (AED)
| Date | Feb 22, 2006 (initiated Feb 1, 2006) |
| Status | Terminated |
| Reason | Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative. |
| Root cause | Nonconforming Material/Component |
| Action | On 2/1/06 the firm issued an UREGENT MEDICAL DEVICE CORRECTION letter to customers via certified return receipt. The letter advised customers of the issue and recommended customers inspect their AED at least weekly. The letter also advised customers what to do when readiness indicator displays certain symbols. The firm''s representatives will visit customers to replace the main circuit board assembly. |
| Quantity | 2100 domestically, 1980 internationally |
| Distribution | Devices were distributed domestically to first responder type consignees and internationally to distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.