Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
This recall has been terminated (originally issued March 31, 2014).
- Company
- Zoll Medical Corporation
- Recall Initiated
- March 5, 2014
- Posted
- March 31, 2014
- Terminated
- January 29, 2021
- Recall Number
- Z-1311-2014
- Quantity
- 3,169 units
- Firm Location
- Chelmsford, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
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.
Lot / Code Info
System Software Version 02.10.02.00 or Higher
Root Cause
Software design
Action Taken
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) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.