Hamilton Medical, Inc. recalls Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Ham…

Recall date

March 9, 2016

Source

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

Recall number

Z-1624-2016

FDA classification

Class II

Brand / firm

Hamilton Medical, Inc.

Sold / distributed

US distribution only.

Why it was recalled

After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.

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 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.