Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
FDA device recall Z-1892-2010 · posted 2010-06-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 3 units
- Distribution
- Nationwide Distribution -- Including CT, NM, & WI.
- Date initiated
- 2010-04-06
- Date posted
- 2010-06-24
- Date terminated
- 2012-07-05
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |