Events

Recall of Fujifilm MS Swivel Arm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00961-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00961-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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