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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00869-1
Product Name/Description Merge OrthoCase with software versions 3.7.3 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 When using the perpendicular line tool, there is an option to 'snap' the lines together, which prevents the perpendicular lines from extending past the straight/base line. When a perpendicular line measurement is made and saved in a plan, the line measurement value changes when the plan is reloaded. This is due to when the “Snap To Line” feature is enabled, it doesn’t apply automatically when the perpendicular line is drawn. It only gets applied when the saved plan is reloaded, so to the user, the measurements look different from what was saved. However, in each case (before/after “Snap to Line” is applied), the line measurement is accurate.
If the line end point is within 20 pixels of the base line, it will adjust its location to snap perfectly to the base line. This may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.
This may cause delay in diagnosis or treatment of patient, however the actual measurement of the line is accurate.
Recall Action Recall for Product Correction
Recall Action Instructions Emergo is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been clsoed-out on 27/02/2017.
Contact Information 02 9006 1662 – Emergo Australia