| 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 |
|
| 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 |