FDA-Device2018-01-24Class II
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.
Zoll Manufacturing Corp.
Hazard
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Sold states
US Nationwide
Affected count
33,670 units
Manufactured in
121 Gamma Dr, N/A, Pittsburgh, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief