Device Recall Innova 2000 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
    52703
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2240-2009
  • 사례 시작날짜
    2009-07-31
  • 사례 출판 날짜
    2009-09-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    Ge healthcare has recently became aware of a potential power supply failure with the innova¿ 2000, 3100 and 4100 systems that may impact patient safety. a potential power supply failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. should this occur, the system cannot be restarted.
  • 조치
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.

Device

  • 모델명 / 제조번호(시리얼번호)
    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422771BU6 00000421701BU4 00000422469BU7 00000394209BU1 00000392580BU7 00000416864BU7 00000418000BU6 00000407955BU4 00000406792BU2 00000427204BU3 000000393456U9 00000406785BU6 00000394044BU2 00000408600BU5 00000421608BU1 00000411914BU5 00000423019BU9 00000398007BU5 00000389235BU3 00000397408BU6 00000387191BU0 and 00000403958BU2.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
  • 제품 설명
    GE, Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
  • Manufacturer

Manufacturer

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