Events

ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35) 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-00539-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00539-1
  • 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 following issues may occur with cardiovascular studies after upgrading from software version 2.0 or 3.0 to software version 3.5 and restoring user-defined presets. this applies to all transducers except the 9l4 and 6c1 hd transducers:- the system may incorrectly display the colour flow data in the wrong position. the potential risk to the patient is misdiagnosis based on erroneous color flow data.The following issue may occur with software version 3.5:- when you adjust the doppler frequency, the system does not restart the pulsed wave doppler or continuous wave doppler waveform. however, the system displays previous doppler data using the new doppler scale which may result in inaccurate measurement values. the potential risk to the patient is misdiagnosis based on the same doppler profile providing two different velocity measurement values.
  • 조치
    Siemens is advising their customers to use factory default presets with software version 3.5 instead of user defined presets restored from software version 2.0 or 3.0. After adjusting the Doppler frequency, freeze and un-freeze the system to refresh the display of the Doppler spectrum resulting in the correct measurements. Siemens will be replacing the software of all affected devices. Thia action has been closed-out on 28/01/2016

Device

ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)
  • 모델명 / 제조번호(시리얼번호)
    ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd