| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00303-1 |
| Product Name/Description |
syngo WorkFlow MLR with version VB30C_FP1, VB30E, VB35A, VB36A and "Portal Radiologist" license (radiology information system used to process data)
ARTG Number: 184557 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
If procedures requested have been deleted or changed (eg. because a procedure was replaced by a better fitting one in syngo Workflow browser or Portal Radiologist), and the clinical information (risk factors, lab values, reason, diagnosis) was changed after the procedure was changed, then outdated clinical information (risk factors, lab values, reason, diagnosis) could be displayed in the user interface and saved (reason is that the outdated procedure with the outdated clinical information is used). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing users with work around instructions to prevent the problem occurring and is also developing a software correction to permanently correct the problem. |
| Contact Information |
1800 310 300 - Siemens Technical Assistance |