Events

Recall of FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray 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-2013-RN-00089-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00089-2
  • 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 australia has been advised that in rare cases, if the exposure conditions (kv and mas values) are changed manually on the control panel and the collimator lamp is turned on while concurrently pressing the electromagnetic break release switch on the collimator handle, the exposure settings are automatically reset to the values initially entered from the console.
  • Action
    Users are advised to reconfirm displayed values before performing exposure. A software update will be provided to customers to correct the issue.

Device

FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)
  • Model / Serial
    FCR Go 2 (FCR-MB201) X-Ray System (Digital general purpose mobile diagnostic x-ray system)ARTG 156199
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd