| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00842-1 |
| Product Name/Description |
syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD)
ARTG Number: 224616 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified the following five system software feature issues with the syngo lab data manager:-
- Result Unit Conversion;
- Quality Control Processing;
- Virus Protection;
- System Performance Degradation; and
- Order received from LIS is Rejected.
If an issue were to exist the user would be made aware via system alerts, Quality Control processing status or standard syngo LDM rule validation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing system configuration modifications to correct the identified issues. Siemens is not recommending a look back of previously generated results.
This action has been closed out on 10/03/2020 |
| Contact Information |
1800 310 300 Siemens Technical Support Centre |