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U.S. Department of Health and Human Services

Medical Device Recalls

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 Medical Device Recallssee related information
Recall Status1 Terminated
Recall Number Z-0010-2014
Recall Event ID 66250
Product GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.

Intended for volume or pressure control ventilation.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-345-2700
Manufacturer Reason
for Recall
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
Action Consignees were sent on 8/28/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 28, 2013. The letter was addressed to Chief of Anesthesia, Health Care Administrator / Risk Manager and director of Biomedical / clinical engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (1-800-345-2700 US).
Quantity in Commerce 911 (252 US, 659 OUS)
Distribution 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.

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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