Events

Recall of Device Recall GE DatexOhmeda Amingo Anesthesia System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56599
  • Event Risk Class
    Class 2
  • Event Number
    Z-0010-2011
  • Event Initiated Date
    2010-08-30
  • Event Date Posted
    2010-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94057
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    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.
  • 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.

Device

Device Recall GE DatexOhmeda Amingo Anesthesia System
  • Model / Serial
    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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA