Hamilton Medical, Inc. recalls HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is de…

Recall date

April 22, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0151-2016

FDA classification

Class I

Brand / firm

Hamilton Medical, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

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).

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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