Recall Z-0836-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK CR Plus defibrillator
| Date | Jun 21, 2007 (initiated Oct 5, 2006) |
| Status | Terminated |
| Reason | Premature battery depletion due to electrical component failure |
| Root cause | Nonconforming Material/Component |
| Action | Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a reg |
| Quantity | Total of CR Plus 13,741 units worldwide; amount does not include units distributed to Japan. |
| Distribution | Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries. |
| 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 |