Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Hig
FDA device recall Z-1311-2014 · posted 2014-03-31 · Terminated
Recall details
- Recalling firm
- ZOLL Medical Corporation
- Reason for recall
- Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, I
- Date initiated
- 2014-03-05
- Date posted
- 2014-03-31
- Date terminated
- 2021-01-29
- Location
- Chelmsford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZOLL PROPAQ XM (K121367) | ZOLL Medical Corporation | 2012-06-21 |
| ZOLL PROPAQ MD (K112761) | Zoll Medical Corporation, World Wide Headquarters | 2012-04-25 |
| ZOLL X SERIES (K112432) | Zoll Medical Corporation, World Wide Headquarters | 2012-03-21 |