Events

Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy) 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-2012-RN-00852-3
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-08-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00852-3
  • 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
    Varian is notifying customers of an anomaly identified with the clinac, trilogy, novalis tx and unique jaw carriers. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an under-dose of the intended target volume.
  • 조치
    Onsite inspection and replacement of jaw carriers. This action has been closed-out on 18/02/2016.

Device

Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radi...
  • 모델명 / 제조번호(시리얼번호)
    Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy)Product codes: H14, H18, H29Affected Serial Numbers: H140865, H140898, H140899 and H294667ARTG Number: 116839
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd