Events

ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A) 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-00563-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00563-1
  • 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
    When using the 9l4 transducer in combination with virtual touch quantification (vtq), the displayed mechanical index (ie, the ml value which reflects the risk of mechanical cavitation that could cause tissue damage) may be outside the stated tolerance of +/=15%. this occurs only between the depths of 2.5cm and 3.4cm. to date, no patient injury has been reported.
  • 조치
    Users are advised that the MI values should be interpreted as relative information and used only to assist the operators in implementing the ALARA (As Low As Reasonably Achievable) principle during patient examinations. For systems with software version VC25, Siemens is updating the Instructions for Use regarding the tolerance of the Mechanical Index (MI) displayed values. For systems with software version VC30A, Siemens is updating the software. This action has been closed-out on 18/02/2016.

Device

ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (...
  • 모델명 / 제조번호(시리얼번호)
    ACUSON S2000 and ACUSON S3000 Ultrasound Systems (software version VC25) or with HELX Evolution (software version VC30A)Catalogue numbers: 10041461, 10440017 and 10441730ARTG Number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd