FDA-Device2013-10-23Class I
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
GE Healthcare, LLC
Hazard
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
Sold states
Worldwide Distribution-USA (nationwide) including the states of US: AK, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MD, MI, MN, MS, MT, NV, NY, NC, OH, OR, PA, SC, TX, WY, and WI and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COST ARICA, CROATIA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KAZAHHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LITHUANIA, MAURITITUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPINES, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, and VENEZUELA.
Affected count
911 (252 US, 659 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2014Don't want to check this manually?
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