Events

Fujifilm MS Swivel Arm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fujifilm Australia 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-2017-RN-00961-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00961-1
  • 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
    Fujifilm has become aware of a potential issue with the fujifilm ms (mammography system) swivel arm. it was found that in one case, the coupling key connecting the ball screw and the motor for moving the swivel arm up/down of the fdr ms-3500 was removed, causing the swivel arm to move downwards. whilst the probability of this occurring is considered to be very low, fujifilm wishes to reduce any potential risk to patients by undertaking this action.
  • 조치
    Fujifilm is requesting that: 1. Once a Fujifilm engineer has checked and tightened the coupling key, users will need to complete the Customer Feedback form supplied with the original Customer Letter and return it by post, fax or email as per the instructions given.

Device

Fujifilm MS Swivel Arm
  • 모델명 / 제조번호(시리얼번호)
    Fujifilm MS Swivel ArmSerial Numbers:MS-3500 (76221095 or earlier)MS-2500 (Made in Japan - 16640001 or later)MS-2500 (Made in China - 26860001 or later)MS-2000 (Made in Japan - 16650001 or later)MS-2000 (Made in China - 26870001 or later)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd