Events

Device Recall GE OEC 9800 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE OEC Medical Systems, Inc 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
    51222
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2038-2012
  • 사례 시작날짜
    2008-02-22
  • 사례 출판 날짜
    2012-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79254
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being classified by the agency. the vertical lift column power supply in the mainframe c-arm of the device is defective and subject to early life failure.
  • 조치
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The firm, GE Healthcare, Surgery, sent an "URGENT RECALL NOTICE" dated November 8, 2006 via certified mail with return receipt request to consignees/customers with specific instructions. Customers were advised "to stop using the system WITH NAVIGATION until this replacement has been successfully completed. OEC@ FluoroTrak 9800 Plus system may be used as a standard C-Arm providing you review the other issues as listed below." GEHC OEC is actively working on solutions that will permanently resolve each of the noted issues. If you have any questions or concerns regarding these issues, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Information is available at this number 24 hours per day, 7 days a week.

Device

Device Recall GE OEC 9800
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. || The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA