RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Varian Medical Systems Australasia Pty 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-00371-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-24
  • 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
    While operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. the error may be reproduced if the rpm system is induced to frequently lose and reacquire tracking of the 6-dot marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • 조치
    Varian is providing temporary work around instructions and is implementing a software update to permanently correct the problem.

Device

  • 모델명 / 제조번호(시리얼번호)
    RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems) Product code: H50Multiple serial numbers affectedARTG Number: 117951
  • Manufacturer

Manufacturer