Pittsburgh, PA, United States
Zoll Manufacturing Corp. recalls
1 recall recorded since 2018, most recently on 12 September 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 September 2017
- Terminated
- 10 August 2021
- Reason
- Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0353-2018
- 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 r
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.