Events

Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) 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-00401-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-04-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00401-1
  • 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
    The manufacturer has advised that the use of the neonate head protocol with the paediatric kernel hp38 could result in artefacts and possibly lead to misdiagnosis. either not existing blood or liquid is mimicked in the images or actually existing blood or liquid is not depicted as expected. investigations revealed a wrong parameterisation of the reconstruction algorithm applied for the paediatric head kernel as cause of the problem. this does not affect other kernels or reconstruction modes.
  • 조치
    Siemens is advising users not to use the Neonate Head protocol with paediatric kernel Hp38 and is recommending using kernel Hr38 instead. The reconstruction of images is based on raw data, the data acquisition parameters are not affected and no additional dose is applied to the patient. A software upgrade will be performed as a permanent correction. This action has been closed-out on 03/02/2017.

Device

Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed T...
  • 모델명 / 제조번호(시리얼번호)
    Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)Catalogue Number: 10742326 ARTG Number: 164065
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd