Events

ACUSON SC2000 Ultrasound Systems 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-00076-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00076-1
  • 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 locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel. if the locking mechanism fails, there is the potential risk the user will be unable to steer or control the ultrasound system during transport.
  • 조치
    Siemens is advising that if a user is unable to lock the rotation of the control panel or experiences rotation of the control panel or progressively greater left to right movement when the control panel lock is engaged, park the ultrasound system and contact Siemens. Siemens will be contacting all affected users to make the required repairs to the affected systems.

Device

ACUSON SC2000 Ultrasound Systems
  • 모델명 / 제조번호(시리얼번호)
    ACUSON SC2000 Ultrasound SystemsSerial Numbers: 401100 to 401400ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd