Events

Philips MobileDiagnost wDR Mobile Digital X Ray System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems DMC GmbH 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
    16733
  • 사례 시작날짜
    2014-05-19
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 원인
    Under very specific error conditions the system executes an unintended exposure:, * the hand switch is erroneously stuck in pressed position, while the system is switched off,, * the system is powered up with the hand switch in that erroneous condition,, * the user logs in, selects a patient for examination, gets a green ready light in,, * the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.
  • 조치
    Software to be upgraded

Device

Philips MobileDiagnost wDR Mobile Digital X Ray System

Manufacturer

Philips Medical Systems DMC GmbH
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA