Events

GE Precision and Advantx Legacy/Legacy-D Radiographic and Fluroscopic Systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 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
    18755
  • 사례 시작날짜
    2015-06-29
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 원인
    The spot film device (sfd) or intelegent digital device (idd) safety mechanism installed on the system may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1" (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.
  • 조치
    Product to be modified

Device

GE Precision and Advantx Legacy/Legacy-D Radiographic and Fluroscopic Systems
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: All serial numbers
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC