Device product
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Z-1311-2014
Product summary
- Event
- Event 67749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,169 units
- Official record key
device-enforcement:Z-1311-2014
Official wording
Reason: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Code information: System Software Version 02.10.02.00 or Higher
Distribution pattern: 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.
Derived failure modes
-
Unknown
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used