Events

Acuson 2000 ultrasound system (with structural foam core). 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-2016-RN-00360-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00360-1
  • 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 metal component used to engage the lock on the wheels may disconnect, preventing the user from locking and unlocking or steering the wheels.In the event this issue occurs when the wheels are in the “unlocked” position and the user attempts to move the system, the user may lose balance. if the wheels are in the “locked” position and the user attempts to move the system, the user may sustain soft tissue damage or strain. to date, no patient injury has been reported.
  • 조치
    Siemens is advising that there are no known steps the user can take to prevent the issue from occurring. Siemens will be modifying the wheel assembly on affected systems as a permanent correction.

Device

Acuson 2000 ultrasound system (with structural foam core).
  • 모델명 / 제조번호(시리얼번호)
    Acuson 2000 ultrasound system (with structural foam core).Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd