| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00425-1 |
| Product Name/Description |
syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiology picture archiving and communication system)
ARTG number: 120332 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to syngo Dynamics. In this case during “in-progress” a study will get a SensisRefNo for the wrong study in Sensis. This will cause an incorrect link between syngo Dynamics images and the Sensis study data. When a patient study is opened in syngo Dynamics a Sensis report of another patient study is shown.
The preconditions for this to occur are:
- Sensis-syngo Dynamics integration
- Sensis study is opened from syngo Dynamics while still "in progress"
- Sensis reference number is > 1000,000
This could result in patient mismatch or a persistent unintended change to patient data could result. The patient mismatch is detectable when the study is opened for the first time if the toolbar is not configured to auto-hide. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is preparing a service patch modification that will resolve the potential malfunction. In the interim, end users are requested to discontinue opening "in progress" studies and to configure the “AXIOM Artis AE” title in syngo Dynamics to "Other" type of station. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |