Events

SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system) 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-2016-RN-01461-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01461-1
  • 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
    Customers with software version va50_sp2 will be provided an update to software version va50_sp3. the installation of this update will address software bugs that were identified through field monitoring. some of the major bug fixes that will be addressed with this software are:1) correction to volumetric misrepresentations of high contrast objects when using admire.2) correction to highly sporadic scan aborts due to temporarily tube currents at 0ma.3) correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4) correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.5) correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.6) correction to highly sporadic scan aborts due to temporarily high disk load of system disk.7) correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing.
  • 조치
    Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite.

Device

SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)ARTG Number : 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd