Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2017-RN-01387-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-08
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Philips have identified multiple issues with the philips brilliance 64 / ingenuity family running software version 4.1.6issue 1: cardiac signal not found in workflow issueissue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to startissue 3: pulmo gates on cardiac workflow issueissue 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 issueissue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error messageissue 10: issue with the generator monitor state machine in rhost code issuethere have been no injuries reported as a result of these issues.
  • 조치
    Philips is providing users with work around instructions to follow as an interim measure. Philips will be performing a software update as a permanent correction.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips Brilliance 64, Ingenuity Core128 and Ingenuity CT with software version 4.1.6ARTG Number: 98868
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA