Events

Recall of Fujifilm Access Point for FDR Go Flex ­– DR-ID 1200 AP KIT E(Computed radiographic 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-2016-RN-01522-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01522-1
  • 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
    It was identified that the current labelling of the fujifilm wireless access point is not in keeping with australian legislative requirements for regulatory compliance mark (rcm). the dr-id 1200 ap kit e is compliant with the rcm and should be labelled accordingly with the certification label.
  • Action
    A new sticker with the Regulatory Compliance Mark will be supplied for the access points for customers to apply to the device .

Device

Fujifilm Access Point for FDR Go Flex ­– DR-ID 1200 AP KIT E(Computed radiographic system)
  • Model / Serial
    Fujifilm Access Point for FDR Go Flex ­– DR-ID 1200 AP KIT E(Computed radiographic system)ARTG number: 175809
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd