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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00854-1
Product Name/Description syngo Workflow MLR using Portal Radiologist

Software versions: VB30C, VB30E, VB30F, VB35A, VB35B, VB36A and VB37A

Catalogue Number: 10014099

ARTG Number: 274609
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 11/07/2017
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens has identified a potential issue with syngo Workflow MLR where reports signed off in Portal Radiologist are sporadically not transferred to external systems. Due to irregular synchronisation issues within an MLR application internal process, it can fail to return the appropriate data. The report will not be shared with external systems however the report content is intact within syngo Workflow MLR.
Recall Action Recall for Product Correction
Recall Action Instructions For the 'Affected versions' of syngo Workflow MLR, a fix of this potential malfunction is in preparation by Siemens Healthcare GmbH via the upcoming syngo Workflow MLR software update version VB37B this issue will be resolved.

This action has been closed out on 12/10/2018
Contact Information 1800 310 300 - Siemens Customer Care Centre