Events

Recall of Amulet (FDR MS-1000), Amulet f (FDR MS-2500) & Amulet Innovality (FDR MS-3500) with Biopsy Unit

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-2015-RN-00108-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00108-1
  • 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
    During a biopsy study using the fujifilm digital mammography system, it has been found that the user manual lacks a description for handling some errors. if users do not address the recovery procedure properly, there may be a possibility that the examination is suspended leading to patient re-examination.
  • Action
    FujiFilm has developed a simplified manual describing the recovery procedure which will be circulated to customers. This action has been closed-out o 08/08/2016.

Device

Amulet (FDR MS-1000), Amulet f (FDR MS-2500) & Amulet Innovality (FDR MS-3500) with Biopsy Unit
  • Model / Serial
    Amulet (FDR MS-1000), Amulet f (FDR MS-2500) & Amulet Innovality (FDR MS-3500) with Biopsy Unit Serial Numbers: 26340096, 37220054 & 36920025ARTG Number: 159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd