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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00862-1
Product Name/Description Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications system)

ARTG Number: 191068
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/06/2016
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the Java running out of memory. This may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. This may result in a delay in diagnosis or treatment or patient misdiagnosis. There have been no reports of injuries as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017.
Contact Information 02 9006 1662 – Emergo Australia