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GE Healthcare, LLC recalls GE Healthcare, Avance, Avance CS2, Amingo.
Recalled December 21, 2016 · FDA recall Z-0755-2017 · GE Healthcare
Hazard
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. · FDA Class II
Units
23,098 (US = 8,711; OUS = 14,387)
Sold at
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 Estonia Ethiopia Finland FRANCE Georgia GERMANY Ghana Gibraltar GREECE HONG KONG HUNGARIA Iceland India Indonesia IRAQ Ireland Israel ITALY JAPAN JORDAN KAZAKHSTAN Kenya KOREA, REPUBLIC OF Kuwait Latvia Lebanon Libyan Arab Jamahiriya LITHUANIA MACEDONIA MALAYSIA Malta Mexico MOLDOVA MOROCCO NAMIBIA Netherlands New Zealand Nicaragua Nigeria NORWAY Oman Pakistan Panama PARAGUAY PERU PHILIPPINES Poland PORTUGAL Qatar ROMANIA Russian Federation Saudi Arabia Serbia SERBIA-MONTENE Singapore Slovakia SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN Thailand Tunisia TURKEY Ukraine United Arab Emirates UNITED KINGDOM Uruguay UZBEKISTAN Venezuela VietNam Yemen
Description
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.
Product
GE Healthcare, Avance, Avance CS2, Amingo.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →