CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report

X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor recalled

Zoll Medical is recalling X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System, distributed nationwide in the US. The recall was initiated on 5 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem Software Version 02.10.02.00 or Higher

Quantity recalled3,169 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1311-2014
FDA event ID: 67749
Recalling firm: Zoll Medical, Chelmsford, MA
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2014
FDA classified: 31 Mar 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

5 Mar 2014	Recall initiated by company
31 Mar 2014	Classified by FDA	+26 days
9 Apr 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used

Which lots are affected?

System Software Version 02.10.02.00 or Higher

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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