Events

Recall of Agfa Medical DX-D100 Mobile X-Ray Generator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Agfa-Gevaert NV.

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
    20225
  • Event Initiated Date
    2016-06-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Cass Medical Limited, 803 Paparata Road, Bombay, SOUTH AUCKLAND
  • Reason
    If motorised movement is not possible user is required to switch to manual movement. the manufacturer has updated the user manual to provide instructions to the user on how to perform the change from automatic to manual movement.
  • Action
    Manufacturer to issue advice regarding use

Device

Agfa Medical DX-D100 Mobile X-Ray Generator
  • Model / Serial
    Model: DX-100 Mobile X-Ray, Affected:
  • Manufacturer
    Agfa-Gevaert NV

Manufacturer

Agfa-Gevaert NV