Recall Z-1082-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.
| Date | Apr 10, 2013 (initiated Feb 8, 2013) |
| Status | Terminated |
| Reason | LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue. |
| Root cause | Component design/selection |
| Action | The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement |
| Quantity | 54,197 units in US and 78,627 units internationally (total 132, 824 units) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp., Dec 3, 2001 |