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

Recall Z-0151-2016 — HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients

U.S. FDA — Device Enforcement · United States · 2014-04-22 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0151-2016
Date of alert
2014-04-22
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Hamilton Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
28891599
Reported risk: Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
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.

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