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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00459-1
Product Name/Description IMPAX RIS 5.8 and higher (Picture archiving and communication system software)

ARTG Number: 120846
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/04/2014
Responsible Entity AGFA HealthCare Australia
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 1300 364 612 - Agfa Healthcare Service Help Desk