FDASeptember 12, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
What to do
FDA enforcement status: Terminated
Brands named
zoll manufacturingzoll
Recall history
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