Events

Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option 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-2015-RN-00595-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-07-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00595-1
  • 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 healthcare received complaints that when repositioning the virtual touch iq region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. the maximum error in position between the measurement tool and shear velocity data is 3.8 mm. the issue of concern is a potential underestimation of maximum shear wave velocity of a lesion. this underestimation may lead to a user deciding not to biopsy a cancerous lesion. the potential risk of misdiagnosis associated with this issue is low.
  • 조치
    Siemens Healthcare is requesting the customers not reposition the Virtual Touch IQ region of interest from the original (default) location. Siemens is also requesting the customers to review previously performed studies to ensure the results are as expected. This issue will be resolved in a future software release. This action has been closed-out on 01/03/2018.

Device

Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option
  • 모델명 / 제조번호(시리얼번호)
    Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ optionARTG Number: 137563
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd