Events

Philips iCT and iCT SP CT systems 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Philips Medical Systems (USA) 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
    13192
  • 사례 시작날짜
    2012-07-20
  • 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
    In the ct systems above, sixteen bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off., a risk of serious injury (bone fracture, head injury, concussion) was identified in the event that all sixteen (16) bolts are broken. if this occurs, and the carbon table top is extended, the table top may tilt or tip over, or it may result in unintended pivotal motion of the table. if the patient is not secured to the table, there is a possibility the patient may slide off, which may cause serious injury. if less than sixteen (16) of the j-bracket bolts fail, the carbon table top will remain attached to the couch subframe.
  • 조치
    Product to be modified

Device

Philips iCT and iCT SP CT systems

Manufacturer

Philips Medical Systems (USA)
  • 제조사 모회사 (2017)
    Philips
  • Source
    NZMMDSA