Events

Recall of DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affected

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AGFA HealthCare Australia.

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-00523-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00523-1
  • 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
    Agfa has received a report in which the mechanical detent marker on a dx-d 600 became detached. there have been no reports of injuries associated with this issue.
  • Action
    Agfa HealthCare is advising users that if the mechanical detent markers have become loose, to notify Agfa as soon as possible. Agfa will be inspecting all affected units and correcting where required.

Device

DX-D 600 Digital Radiography System (general purpose x-ray system) Products affected: DX-D 600 Di...
  • Model / Serial
    DX-D 600 Digital Radiography System (general purpose x-ray system)Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic SystemsAll serial numbers affectedARTG Number:173861
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia