BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT) 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-2014-RN-01225-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-11-27
  • 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 has identified the following anomalies that give rise to a potential hazard of unexpected contact between the detector and the patient: 1)following a cardiac scan and when using smartstep to set-up the camera for a relative 180 procedure, it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. this issue only affects brightview xct systems.2) during a patient spect lung acquisition, the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degree position. however, in the middle of a clinical scan acquisition, the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. the movement from 90 degree to the 240 degree may take approximately 7 seconds.There have been no reports of patient injury due to either of these issues to date.
  • 조치
    Philips is advising the customer/user to perform the work-around identified in the customer communication prior to the implementation of the permanent correction, to avoid contact between the detector and the head holder. Also, they are advised to monitor the patient during all system motions and to know locations of the multiple E-Stop button(s) to halt all system motions, if required. The correction will consist of the installation of BrightView Family software version 1.2.4/2.5.4.

Device

  • 모델명 / 제조번호(시리얼번호)
    BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT) ARTG number: 117440
  • 의료기기 분류등급
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA