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GE Healthcare, LLC recalls GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Recalled October 23, 2013 · FDA recall Z-0009-2014 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv · FDA Class I
Units
10,263 (3,194 US, 7,069 OUS)
Sold at
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico except DE, ME, NM, RI, and VT, and the countries of UNITED ARAB EMIRATES, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA , MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED KINGDOM, VIETNAM, URUGUAY, and VENEZUELA.
Description
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
Product
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →