Moderate FDA (Devices)·Z-2401-2012·Announced 2012-09-26

Zoll X Series Defibrillators Recalled for Incorrect Software

ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

ZOLL Medical Corporation is recalling 11 units of the Zoll X Series Defibrillator/Pacemaker/Monitor. The recall was initiated because the devices were shipped with incorrect software.

The affected devices are used by qualified medical personnel to convert ventricular fibrillation to sinus rhythm, terminate certain tachycardias, provide cardiac pacing, and monitor electrocardiograms (ECG). The recall covers units distributed worldwide, including nationwide in the United States (specifically in LA, MA, ME, NC, ND, NE, and OH) and in Germany.

Healthcare facilities and users should contact ZOLL Medical Corporation for instructions on how to resolve the software issue. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

Product: 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 add
Manufacturer: ZOLL Medical Corporation
Category: Medical Device — Defibrillator
Hazard: software-error
Affected units: 11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · ZOLL Medical Corporation

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Same hazard · software error