Recall Z-1892-2010 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
| Date | Jun 24, 2010 (initiated Apr 6, 2010) |
| Status | Terminated |
| Reason | Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs. |
| Root cause | Device Design |
| Action | The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded. |
| Quantity | 3 units |
| Distribution | Nationwide Distribution -- Including CT, NM, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |