Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
FDA device recall Z-0465-2013 · posted 2012-12-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could
- Action taken
- The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 15
- Distribution
- Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
- Date initiated
- 2012-06-20
- Date posted
- 2012-12-03
- Date terminated
- 2014-01-14
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA (K093612) | Siemens AG Medical Solutions | 2010-03-04 |