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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Amingo Anesthesia System

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  Class 2 Device Recall GE DatexOhmeda Amingo Anesthesia System see related information
Date Initiated by Firm August 30, 2010
Date Posted October 06, 2010
Recall Status1 Terminated 3 on September 13, 2012
Recall Number Z-0010-2011
Recall Event ID 56599
510(K)Number K081844  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Code Information AMNM00101 AMNM00102 AMNM00103 AMNM00104 AMNM00105 AMNM00106 AMNM00107 AMNM00108 AMNM00109 AMNM00110 AMNM00111 AMNM00112 AMNM00113 AMNM00114 AMNM00115 AMNM00116 AMNM00117 AMNM00118 AMNM00119 AMNM00120 AMNM00121 AMNM00122 AMNM00123 AMNM00124 AMNM00125 AMNM00126 AMNM00127 AMNM00128 AMNM00129 AMNM00130 AMNM00131 AMNM00132 AMNM00133 AMNM00134 AMNM00135 AMNM00136 AMNM00137 AMNM00138 AMNM00139 AMNM00140 AMNM00141 AMNM00142 AMNM00143 AMNM00144 AMNM00145 AMNM00146 AMNM00147 AMNM00148 AMNM00149 AMNM00150 AMNM00151 AMNM00152 AMNM00153 AMNM00154 AMNM00155 AMNM00156 AMNN00100 AMNN00101 AMNN00102 AMNN00103 AMNN00104 AMNN00105 AMNN00106 AMNN00107 AMNN00108 AMNN00109 AMNN00110 AMNN00111 AMNN00112 AMNN00113 AMNN00114 AMNN00115 AMNN00116 AMNN00117 AMNN00118 AMNN00119 AMNN00120 AMNN00121 AMNN00122 AMNN00123 AMNN00124 AMNN00125 AMNN00126 AMNN00127 AMNN00128 AMNN00129 AMNN00130 AMNN00131 AMNN00132 AMNN00133 AMNN00134 AMNN00135 AMNN00136 AMNN00137 AMNN00138 AMNN00139 AMNN00140 AMNN00141 AMNN00142 AMNN00143 AMNN00144 AMNN00145 AMNN00146 AMNN00147 AMNN00148 AMNN00149 AMNN00150 AMNN00151 AMNN00152 AMNN00156 AMNN00157 AMNN00158 AMNN00159 AMNN00160 AMNN00161 AMNN00162 AMNN00163 AMNN00164 AMNP00100 AMNP00101 AMNP00102 AMNP00103 AMNP00104 AMNP00105 AMNP00106 AMNP00107 AMNP00108 AMNP00109 AMNP00110 AMNP00111 AMNP00112 
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 131
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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