Zoll Manufacturing Corp. recalls LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 1…
- Recall date
- September 12, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0353-2018
- FDA classification
- Class II
- Brand / firm
- Zoll Manufacturing Corp.
- Sold / distributed
- US Nationwide
Why it was recalled
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
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