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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Aisys Anesthesia System

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 Class 2 Device Recall GE DatexOhmeda Aisys Anesthesia System see related information
Date Posted October 06, 2010
Recall Status1 Terminated on September 13, 2012
Recall Number Z-0008-2011
Recall Event ID 56599
510(K)Number K090233 
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Code Information 377
ANAK00380
ANAK00381
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ANAK00464
ANAK00465
ANAK00471
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ANAK00478
ANAK00479
ANAK00480
ANAK00492
ANAK00506
ANAK00509
ANAK00510
ANAK00511
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ANAK00513
ANAK00514
ANAK00526
ANAK00527
ANAK00528
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ANAK00579
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ANAK00681
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ANAK00720
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ANAK00727
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ANAK00758
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ANAK00771
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ANAK00906
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ANAK00908
ANAK00909
ANAK00910
ANAK00922
ANAK00923
ANAK00924
ANAK00925
ANAK00926
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ANAK00928
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ANAK00937
ANAL00100
ANAL00101
ANAL00102
ANAL00105
ANAL00106
ANAL00107
ANAL00108
ANAL00109
ANAL00116
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AN
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila
FDA Determined
Cause 2
Employee error
Action GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. 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, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
Quantity in Commerce 3039
Distribution Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.
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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