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

Recall Z-2142-2023 — HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

U.S. FDA — Device Enforcement · United States · 2023-06-15 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2142-2023
Date of alert
2023-06-15
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Hamilton Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07630002801881
Reported risk: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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