# FDA recall Z-0353-2018

> **Zoll Manufacturing Corp.** · Class II · device recall initiated 2017-09-12.

## 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 for recall

Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0353-2018
- **Recalling firm:** Zoll Manufacturing Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-12
- **Report date:** 2018-01-24
- **Termination date:** 2021-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2018

## Citation

> AI Analytics. FDA recall Z-0353-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0353-2018. Source: US FDA. Licensed CC0.

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