Events

Recall of FUJIFILM General X-ray System FDR Smart f series

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-2018-RN-00351-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00351-1
  • 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 fdr smart f systems should have been sold and installed with the stated condition of:“operation in the shielded room over 20 db radiated emission attenuation”. the units have been sold with no such condition being stated.
  • Action
    Fujifilm are advising service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures. Correction will include the addition of ferrite cores, cable shielding and replacement of internal hardware and a firmware update.

Device

FUJIFILM General X-ray System FDR Smart f series
  • Model / Serial
    FUJIFILM General X-ray System FDR Smart f seriesARTG Number: 197063Fujifilm Australia - X-ray system, diagnostic, general-purpose, stationary, analogue
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd