Events

Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license) 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-2014-RN-01318-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01318-1
  • 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 potential malfunction which can occur when composed images are flipped on the integrated imaging system flourospot compact. when composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. the affected images and associated annotations such as labels (e.G. r/l) may show incorrectly.The corrupt image information might lead to an incorrect diagnosis.
  • 조치
    Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.

Device

Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho...
  • 모델명 / 제조번호(시리얼번호)
    Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license) ARTG Number: 102182, 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd