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Zoll Manufacturing Corp. recalls LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients
Recalled January 24, 2018 · FDA recall Z-0353-2018 · Zoll Manufacturing
Hazard
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure · FDA Class II
Units
33,670 units
Sold at
US Nationwide
Description
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Product
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.
Manufacturer(s)
Zoll Manufacturing Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →