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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00287-1
Product Name/Description syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)

ARTG Number: 120332
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/03/2014
Responsible Entity Siemens Ltd
Reason/Issue A software error could allow for two different patients to be displayed in syngo Dynamics where, images shown for one patient and reporting system data (worksheet and/or report) shown for a different patient potentially resulting in misdiagnosis due to mix-up in patient data. When this error occurs, a previously opened study is not properly disconnected from the Sensis hemodynamics system. Only customers using Sensis-syngo Dynamics integration will face the occasional probability of this error occurring.
Recall Action Recall for Product Correction
Recall Action Instructions demographics to review the image toolbar and reporting system, and to ensure that toolbar "auto-hide" is disabled. If a patient mismatch is observed, users are advised to close and reopen the study. A software update will be implemented as a corrective measure. This action has been closed-out on 29/01/2016.
Contact Information 1800 310 300 - Siemens Technical Support Centre