Events

Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2015-RN-00550-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00550-1
  • 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
    Due to a production fault in a specific production lot of the triple-focus x-ray tube assembly, there is a possibility that the "small focus" may fail. if this occurs, no further radiation release will be possible from this focus source. the "large focus" and "micro focus" will still be operational.
  • 조치
    This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016.

Device

Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly
  • 모델명 / 제조번호(시리얼번호)
    Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assemblyCatalogue/Lot numbers: X-ray tube assemblies 10144184 and 10145086 from a specific production lotARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd