Events

Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Medical Systems, 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
    73383
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1381-2016
  • 사례 시작날짜
    2016-02-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143994
  • 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
    Ge healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all aisys cs2 and upgraded aisys anesthesia devices.
  • 조치
    Consignees were sent on 2/17/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34075 dated February 17, 2016.The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.
  • 제품 설명
    GE Healthcare, Aisys CS2 anesthesia..
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA