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Terminated

GE Healthcare, Avance, Avance CS2, Amingo.

FDA Recall Z-0755-2017 · Posted None

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2016-11-03
Date Terminated2018-09-17
Product Quantity23,098 (US = 8,711; OUS = 14,387)

Reason for Recall

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.

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 34079 dated November 3, 2016, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131945GE DATEX-OHMEDA AVANCE CS2Datex-Ohmeda · 2013-08-08K112722GE DATEX-OHMEDA AVANCEDatex-Ohmeda, Inc. · 2011-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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