Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop
Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a critical medical device that may become unusable during an emergency, posing a significant risk of harm to patients.
Plain-English summary
Zoll Medical Corporation is recalling 3,169 units of X Series, PropaqMD, and PropaqM Defibrillator/Pacemaker/Monitor devices. The affected units are equipped with System Software Version 02.10.02.00 or higher. These devices are distributed nationwide in the United States and internationally to numerous countries including Canada, Australia, China, France, and Japan.
The recall is issued because the devices may latch in a continuous device reset loop. When this occurs, the defibrillator/pacemaker/monitor cannot be used. This defect poses a risk to patients who require the device for emergency medical treatment.
Consumers and healthcare facilities should stop using the affected devices immediately. Users should contact Zoll Medical Corporation for instructions on how to resolve the issue or obtain a replacement.
The recalled product
- Product
- Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
- Manufacturer
- ZOLL Medical Corporation
- Category
- Medical Device — Defibrillator
- Affected units
- 3,169
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 (1)
- System Software Version 02.10.02.00 or Higher
Distribution
Distributed nationwide across the United States.
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