Recall Z-1206-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation, World Wide Headquarters
Zoll AED Plus Defibrillator
| Date | Apr 1, 2009 (initiated Feb 12, 2009) |
| Status | Terminated |
| Reason | Device fails to discharge the defibrillation energy. |
| Root cause | Process design |
| Action | On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every |
| Quantity | 183,535 units |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033474 | ZOLL AED PLUS Zoll Medical Corp, May 21, 2004 |