Events

Recall of Agfa IMPAX RIS

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
    16045
  • Event Initiated Date
    2014-01-29
  • 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
    When batch printing is used for patient reports in qdoc, incorrect patient or referring physician information may be printed on reports. this issue occurs when the microsoft word background printing mechanism is used to send/spool to the printer.
  • Action
    Manufacturer to issue advice regarding use

Device

Agfa IMPAX RIS
  • Model / Serial
    Model: , Affected: , Software version: Version 5.8 and higher
  • Manufacturer
    Agfa-Gevaert NV

Manufacturer

Agfa-Gevaert NV