Events

Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Ingenuity Flex systems 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-2018-RN-00226-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00226-1
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch, there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion.This issue occurs frequently after closing e-stop. the motion controller in the couch detects a power problem and disables the horizontal motor, which allows the couch top to free-float*.*the term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion (manual or automatic motion).
  • 조치
    Philips is advising users that once the E-stop has been closed the operator/technologist must initiate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Philips will be conducting an update to permanently correct the issue.

Device

Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iC...
  • 모델명 / 제조번호(시리얼번호)
    Philips CT couches used on Brilliance CT Big Bore, Brilliance CT Big Bore Oncology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Ingenuity Flex systemsSerial Numbers: 901001 - 901992,911001 - 911221, 921001 - 921369, 931001 - 931044, 941001 - 941137, 951001 - 951130ARTG Numbers: 98868(Philips Electronics Australia - X-ray system, diagnostic, computed tomography, full-body)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA