Events

Artis zee biplane and Artis Q biplane systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2017-RN-01126-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01126-1
  • 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
    Siemens has identified a screw connection in the ceiling mount consisting of 12 screws might not have been attached and fastened according to the quality standards for a specific number of artis zee/q biplane systems. the connection is located within the rotation unit of the second plane.If such screws are not fully tightened in accordance with the specified values, single screws between the c-arm structure of the second plane and its ceiling carriage may become loose. if various screws become loosened over time, this may lead to a recognisable wobble of the c-arm, especially during fast movements. this may result in an acquired image/3d which does not allow for clinical appraisal, resulting in additional x-ray exposure for a patient.There is also the remote possibility that if, after an extended time period, all screws become loosened, parts of the second plane mechanics may become detached from the ceiling carriage of the system, and could hurt the patient and/or personnel.
  • 조치
    Siemens will arrange for all potentially affected systems to be examined. All affected systems will be modified so as to have the screws tightened.

Device

Artis zee biplane and Artis Q biplane systems
  • 모델명 / 제조번호(시리얼번호)
    Artis zee biplane and Artis Q biplane systemsCatalogue Numbers: 10094141 and 10848282ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd