Z-1311-2014Class II

Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version...

Name: Z-1311-2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version...
Creator: ZOLL Medical Corporation
Published: 2014-03-05
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2014-03-05 / Terminated / root cause: software

FDA source

ZOLL Medical Corporation began a recall of Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator on 2014-03-05. FDA classified it as Class II and gives the reason as "Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1311-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-03-31
Terminated: 2021-01-29
Recalling firm: ZOLL Medical Corporation
Product: Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
Root cause tag: software
FDA 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) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.
Quantity in commerce: 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.
Product codes and lots: System Software Version 02.10.02.00 or Higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1311-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1311-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-31

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)