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U.S. Department of Health and Human Services

Class 1 Device Recall GE Aisys

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 Class 1 Recall
GE Aisys
see related information
Date Posted May 11, 2010
Recall Status1 Terminated on January 30, 2012
Recall Number Z-1526-2010
Recall Event ID 55355
Premarket Notification
510(K) Numbers
K081844  K090233 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor
Code Information Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873
Recalling Firm/
Manufacturer
Ge Healthcare, Llc
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
FDA Determined
Cause 2
DESIGN: Process Design
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in Commerce 15 (OUS)
Distribution Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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