Events

Cleveland CT 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
    22197
  • 사례 시작날짜
    2017-11-06
  • 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
    The manufacturer has become aware of a potential problem with our philips brilliance 64/ ingenuity family version 4.1.6 as detailed below:, issue 1: cardiac signal not found in workflow issue, issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start, issue 3: pulmo gates on cardiac workflow issue, issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well., issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results, issue 6: application may fail when modifying the results plan box during 3d calcium score, issue 7: tube too hot, issue 8: memory overflow issue, issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message, issue 10: issue with the generatormonitor state machine in rhost code issue.
  • 조치
    Manufacturer to issue advice regarding use

Device

Cleveland CT
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: The following CT(Computed Tomography) systems are affected: Brilliance 64 728231, Ingenuity Core128 728323, Ingenuity CT 728326, Software version: Running software version: 4.1.6
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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