Events

BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(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-00327-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-03-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00327-1
  • 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
    The detector braking systems may be rendered ineffective resulting in one or both detectors moving to their mechanical limit. in the case of this kind of failure, the detector motion cannot be halted using normal operator intervention (e-stop, collimator contact sensor activation). the detector(s) may move down onto the patient or operator, potentially resulting in entrapment and/or serious injury or death. any brightview, brightview x or brightview xct where components on the braking system have been serviced is potentially affected. systems that were serviced and received a complete brake assembly are not affected by this issue.
  • 조치
    Customers are advised to immediately discontinue use of the system until Philips Service has undertaken the inspection of the system. The system can be returned for clinical use if the system brakes pass inspection. If the system brakes fail inspection, the system will be returned for clinical use once the correction is implemented.

Device

BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nucl...
  • 모델명 / 제조번호(시리얼번호)
    BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT systems)Affected component(s) or subsystem(s):Radius DrivePart Numbers: 453560304611, 453560312361, 453560303641Tangent DrivePart Numbers: 453560304611, 453560312361, 453560303761Roll DrivePart Numbers: 453560313601, 453560303781, 453560313881ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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