Events

Device Recall GE OEC Brivo 865 plus Laser Aimer 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
    71298
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1638-2015
  • 사례 시작날짜
    2014-05-22
  • 사례 출판 날짜
    2015-06-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137256
  • 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
    Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
  • 원인
    Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the us regulations for laser products.
  • 조치
    GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.

Device

Device Recall GE OEC Brivo 865 plus Laser Aimer
  • 모델명 / 제조번호(시리얼번호)
    OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of: MD, NC, MT, NJ, UT and NY
  • 제품 설명
    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA