Events

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray 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-2013-RN-00038-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00038-1
  • 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
    Philips healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. philips has determined the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake’s screws.
  • 조치
    If the couch moves down unexpectedly, please discontinue use of the device and contact your local Philips Field Service Engineer. A Philips Field Service Engineer will perform a brake repair or replacement on the affected systems to resolve the issue.

Device

Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iC...
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)Multiple serial numbers affectedARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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