CLASS II Device recall · Reported 26 Sep 2012 · FDA Enforcement Report

Zoll X Series Defibrillator/Pacemaker/Monitor recalled by ZOLL Medical

Zoll Medical is recalling Zoll X Series Defibrillator/Pacemaker/Monitor, distributed nationwide in the US. The recall was initiated on 16 Aug 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,

Quantity recalled11 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-2401-2012
FDA event ID: 63004
Recalling firm: Zoll Medical, Chelmsford, MA
Classification: Class II
Status: Terminated
Recall initiated: 16 Aug 2012
FDA classified: 17 Sep 2012
Reported: 26 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

16 Aug 2012	Recall initiated by company
17 Sep 2012	Classified by FDA	+32 days
26 Sep 2012	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

Shipped with incorrect software

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 X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).

Where it was distributed

Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.

Nationwide Louisiana Massachusetts Maine North Carolina North Dakota Nebraska Ohio

Questions about this recall

Why was it recalled?

Shipped with incorrect software

Which lots are affected?

Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,

Where was it sold?

Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.

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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