Events

BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging 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-2016-RN-00787-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00787-1
  • 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
    During a non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan. a certain set of conditions identified in the customer letter are required to create the situation. there have been no reports of any injuries associated with this issue. however, users are reminded to ensure patients are observed closely at all times, and the e-stop is activated to prevent contact with the patient, if required.
  • 조치
    Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.

Device

BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear...
  • 모델명 / 제조번호(시리얼번호)
    BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)Model numbers: 882478, 882482ARTG numbers: 117642, 17440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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