Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 refuse an implantable defibrillator.

U.S. FDA — Device Enforcement · United States · 2017-09-12 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0353-2018
Date of alert: 2017-09-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zoll Manufacturing Corp.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall 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 refuse an implantable defibrillator.

Related