Events

MAGNETOM Combi Dockable Neurosurgery Table 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-01360-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-10-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01360-1
  • 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
    It has been identified that due to a potential manufacturing error, in some cases a potential exists for a sudden drop in table height. this can happen with or without user interaction. the maximum drop in height is 5cm. it is therefore necessary to verify whether the tables are affected and carry out any required corrections.
  • 조치
    Siemens is requesting that users do not use the system until it has been inspected by a Siemens Customer Service Engineer. Further information about the use of system and the necessary corrections will be provided at the time of inspection. Siemens will contact affected users shortly to arrange a suitable inspection time. This action has been closed-out on 27/02/2017.

Device

MAGNETOM Combi Dockable Neurosurgery Table
  • 모델명 / 제조번호(시리얼번호)
    MAGNETOM Combi Dockable Neurosurgery TableCatalogue number: 10684336 and 10684337 ARTG number: 274076
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd