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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Defibrillator
- Hazard
- 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
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