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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00199-1
Product Name/Description IntelePACS InteleViewer software version 4.11.1 P144 (Radiology picture archiving and communication system)

ARTG Number: 149923
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/02/2016
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue Since the introduction of a fix to the measurements algorithm (BZ55214), InteleViewer now uses the ratio of the distance from the source to patient over distance from source to detector to compute a scaling factor to apply to measurements when the Estimated Radiographic Magnification Factor (DICOM (0018,1114)) is not present.

That scaling should only be applied when dealing with a projection radiography modality (CR, DX, MG, PX, RF, or XA), however, it ended up being applied to other modalities, such as CT, generating erroneous measurements.

This software defect could lead radiologists to base their diagnosis/report on wrong anatomical measurements. No patient incidents have been reported at this time.
Recall Action Recall for Product Correction
Recall Action Instructions Emergo is advising users to ensure that they uninstall the affected software version from their workstations and install an alternative version of lnteleViewer (e.g. IV 4-11-1 P143 or IV 4-11-1 P145). Also, users are advised to review the studies that were done with lnteleViewer 4-11-1 Pl44 and determine appropriate follow-up with patients. Users will be provided with the list of potentially affected studies.
Contact Information 02 9006 1662 - Emergo Australia