Siemens syngo.plaza radiological image processing system.
FDA device recall Z-0048-2013 · posted 2012-10-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
- Action taken
- The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 11
- Distribution
- Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
- Date initiated
- 2012-06-06
- Date posted
- 2012-10-11
- Date terminated
- 2013-04-13
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |