Events

Device Recall GE DatexOhmeda Amingo Anesthesia System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    56599
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0010-2011
  • 사례 시작날짜
    2010-08-30
  • 사례 출판 날짜
    2010-10-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94057
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Gas-machine, anesthesia - Product Code BSZ
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA