Events

Recall of IMPAX RIS 5.8 and higher (Picture archiving and communication system software)

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-2014-RN-00459-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00459-1
  • 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
    When batch printing is used to 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.This recall action was carried out prior to the notification of the recall strategy to the tga.
  • Action
    Customers are advised to disable the default background printing for IMPAX RIS by following the instructions in the customer letter. Changing this setting does not influence background printing from other applications.

Device

IMPAX RIS 5.8 and higher (Picture archiving and communication system software)
  • Model / Serial
    IMPAX RIS 5.8 and higher (Picture archiving and communication system software)ARTG Number: 120846
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia