Events

Recall of Fujifilm Digital Mammography System

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-00903-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00903-1
  • 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 identified that in very rare cases, software versions v5.0, v5.1, v5.2, v6.0, v6.1 and v7.00 for specific workstations within the digital mammography system may possibly assign a duplicated id number to exposure images.Transmitting the image with the duplicated id number assigned to a pacs could possibly overwrite the image in an old study stored on the pacs. this would cause an unexpected image to appear when referring to the old study. the image and data of a new study does not have this issue, therefore, there is no effect on a diagnosis.Fujifilm has corrected the software that is the cause of such failure.
  • Action
    FUJIFILM has corrected the software that is the cause of such failure. Actions to be taken by customer/user: Make sure the latest images transmitted to PACS exists in the new study-where it should be. If the image with the duplicated ID number assigned is transmitted to PACS, you will fail to find it in a newly created study. (ie it is missing). This is because the image transmitted to PACS with that error overwrites an existing(older) study image and is stored in another(older) study. If you have this error, please contact your local FUJIFILM office. Although the probability of the above error is very rare, systematically checking that the correct number of images per patient has been transferred to the PACS will make sure in case such errors occur.

Device

Fujifilm Digital Mammography System
  • Model / Serial
    Fujifilm Digital Mammography SystemWorkstations:Amulet (FDR MS-1000)Amulet (FDR MS-2500)Amulet Innovality (FDR MS-3500)CR-IR363AWSSoftware versions: v5.0, v5.1, v5.2, v6.0, v6.1 and v7.0 ARTG Number:159785
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd