Siemens syngo — Class II medical device recall Z-0465-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-12-12, distributed nationwide. Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The U
| Recall number | Z-0465-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2012-06-20 |
| Classified | 2012-12-03 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2014-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Reason classes | software |
| Model numbers | 457, 592 |
Product
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.