Events

Recall of DX-D 100 (Mobile diagnostic x-ray generator)

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-2013-RN-00560-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00560-1
  • 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
    Some agfa healthcare customers have encountered sporadic unintended movement when driving the dx-d 100 mobile unit.
  • Action
    The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop. Customers are advised in the case of unintended movement not try to correct the units’ movement via the drive handle but release the drive handle immediately to stop the unit. If unintended movement is experienced, cusotmers are requested to notify Agfa Service. Affected units are required to be taken out of operation for correction.

Device

DX-D 100 (Mobile diagnostic x-ray generator)

Manufacturer

AGFA HealthCare Australia