Events

Biograph mMR with software version syngo E11P 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-2018-RN-00113-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00113-1
  • 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 been notified by the manufacturer that a mismatch has been identified between orientation labels and displayed anatomy (e.G. in the 3d task card) within the software version syngo e11p. this will lead to wrong attenuation correction of the pet data.The issue occurs when changing the image numbering in transversal mrac protocol (e.G. mrac_caipi_hires protocol) from the default setting "feet>>head" to a customised setting "head>>feet". the original images are labelled correctly, but the composed images are flipped by 180 degrees and shifted.There have been no injuries reported as a result of this issue.
  • 조치
    Siemens is advising that this issue will be corrected in the next service pack syngoE11P-SP03. In the interim, do not change the numbering of images in transversal MRAC protocols (within an MRPET workflow). Follow the user manual. Don't rely only on composed images; always additionally refer to the original images for diagnostic purposes.

Device

Biograph mMR with software version syngo E11P
  • 모델명 / 제조번호(시리얼번호)
    Biograph mMR with software version syngo E11PCatalogue Number:10433372ARTG Number: 274035
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd