Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops
Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a life-support medical device with a functional failure (unexpected stop) that poses a risk of harm, but the source text does not report any specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zoll Circulation, Inc. is recalling the AutoPulse Resuscitation System Model 100. This automatic mechanical chest compressor is intended to be used as an adjunct to manual CPR on adult patients in cases of clinical death. The recall is due to complaints associated with an unexpected stop in compressions.
The recall covers 3,881 units in the United States and 1,846 units in the rest of the world. The devices were distributed worldwide. No specific lot numbers or dates are provided in the source text.
Healthcare facilities and users should stop using the affected devices and contact Zoll Circulation for instructions on the next steps.
The recalled product
- Product
- AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of…
- Manufacturer
- Zoll Circulation, Inc.
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)
- all
Distribution
Distribution scope not specified by the agency.
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