Events

Carestream DRX Revolution X-Ray System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Carestream Health 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
    17828
  • 사례 시작날짜
    2014-12-04
  • 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: Carestream Health New Zealand Ltd, c/- Quigg Partners, Level 7, 28 Brandon St, Wellington
  • 원인
    The manufacturer has received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a drx revolution mobile x-ray system as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. no other reports of this type have been received since the device was introduced into commercial distribution in 2009.
  • 조치
    Product to be modified

Device

Carestream DRX Revolution X-Ray System
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Manufactured prior to 15-Oct-2013
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc