Siemens syngo — Class II medical device recall Z-0048-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-10-17, distributed nationwide. Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short
| Recall number | Z-0048-2013 |
|---|---|
| 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 | 2012-06-06 |
| Classified | 2012-10-11 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Serial numbers | 100138, 100146, 100174, 100177, 100181, 100198, 100201, 100249, 100263, 100401, 100406 |
| Model numbers | 10592457 |
Product
Siemens syngo.plaza radiological image processing system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0048-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.