Recall Z-1311-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
ZOLL Medical Corporation
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
| Date | Mar 31, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used |
| Root cause | Software design |
| Action | Zoll Medical issued a Notification letter daetd March 5, 2014, to all affected consignees. The notification letter provides information on how to avoid the issue and instructs customers to contact ZOLL to get affected devices updated. Customers will be given the option to have a software upgrade kit sent to them to update their devices or return devices to ZOLL Service department in Chelmsford Massachusetts to have the device upgraded with the latest software release (Software version 02.16.04.00). Customers with questions were instructed to contact the 24/7 technical support numbers 1 (800) |
| Quantity | 3,169 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey. |
| FDA record | Open on fda.gov |