Recall Z-0353-2018— Zoll Manufacturing Corp.
Class II · Terminated
Class II FDA medical device recall by Zoll Manufacturing Corp., initiated 2017-09-12, terminated 2021-08-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure.
- Recalling firm
- Zoll Manufacturing Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-12
- Terminated
- 2021-08-10
- Firm location
- Pittsburgh, PA, United States
Product description
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.
Reason for recall
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Data sourced from openFDA. This site is unofficial and independent of the FDA.