Events

Recall of FujiFilm Digital Mammography System AMULET (FDR MS-1000)

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-2013-RN-00768-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00768-1
  • 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
    In rare cases the amulet mammography system may freeze during stereo/biopsy-movement in biopsy examination. once this failure occurs, continued system operation is impossible until a fujifilm technician corrects the issue.
  • Action
    FujiFilm is requesting users to discontinue use of the biopsy unit until the faulty components are replaced. Screening without use of the biopsy unit may still be performed in the interim.

Device

FujiFilm Digital Mammography System AMULET (FDR MS-1000)
  • Model / Serial
    FujiFilm Digital Mammography System AMULET (FDR MS-1000)Serial Number: 07120035ARTG Number: 159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd