Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT 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-2017-RN-00260-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-24
  • 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
    Several issues have been identified with philips brightview, brightview x and brightview xct leading to a need to re-scan the patient:-brightview xct systems only:- motion controller emits the warning message; and- door interlock switch with x ray perform.For both brightview x and xct systems:- detector contacts head holder when performing patient unloadfor brightview, brightview x, and brightview xct systems:- jetstream freezes during gated planar scan.
  • 조치
    Philips is notifying the affected users of these issues via this Customer Information Letter. Customers will be contacted by a Philips Field Service Engineer for implementation of the necessary software corrections free of charge.

Device

  • 모델명 / 제조번호(시리얼번호)
    Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT (Nuclear medicine gamma camera and SPECT/CT systems)Model Number and Device Name: 882480 - BrightViewSoftware versions: 1.2.1, 1.2.2, 1.2.3, 1.2.4 and 1.2.5Model Number and Device Name: 882478 - BrightView X882482 - BrightView XCT882454 - BrightView X upgrade to XCTSoftware versions: 2.5.1, 2.5.2, 2.5.3, 2.5.4 and 2.5.5ARTG Numbers: 117642, 117440
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA