Medical device recalls Moderate risk

Hamilton Medical, Inc. recalls Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700..…

Recall date
March 24, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2057-2015
FDA classification
Class II
Brand / firm
Hamilton Medical, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

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