Z-0353-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- September 12, 2017
- Termination Date
- August 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,670 units
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
Distribution Pattern
US Nationwide
Code Information
All Serial Numbers