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

Recall Z-1874-2019 — HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment wher

U.S. FDA — Device Enforcement · Switzerland · 2019-03-25 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1874-2019
Date of alert: 2019-03-25
Country / jurisdiction: Switzerland
Risk level: Class I
Risk type: recall
Brand: Hamilton Medical AG
Product category: device
Product type: Devices

Reported risk: New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.

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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