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

Recall Z-0812-2018 — 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure venti

U.S. FDA — Device Enforcement · United States · 2017-06-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0812-2018
Date of alert: 2017-06-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ZOLL Medical Corporation
Product category: device
Product type: Devices

Reported risk: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.

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.

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