FDAFDA · Food and drugs·Recall number Z-1311-2014
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Published April 9, 2014 · Recall initiated: March 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ZOLL Medical Corporation
- Distributor
- 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
- System Software Version 02.10.02.00 or Higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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