GE Healthcare, LLC recalls GE Healthcare, Avance, Avance CS2, Amingo.

Recall date

November 3, 2016

Source

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

Recall number

Z-0755-2017

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of Australia AUSTRIA Azerbaijan Bahrain Bangladesh Barbados Belarus Belgium BOLIVIA BOSNIA-HERZEGOVINA Brazil BRUNEI BULGARIA Canada CHILE China COLOMBIA COSTA RICA Croatia Cyprus Czech Republic Denmark ECUADOR Egypt…

Why it was recalled

GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.

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

What was recalled

GE Healthcare, Avance, Avance CS2, Amingo.