Siemens syngo — Class II medical device recall Z-1975-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-08-21, distributed nationwide. Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In
| Recall number | Z-1975-2013 |
|---|---|
| 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 | 2013-03-04 |
| Classified | 2013-08-15 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Serial numbers | 100174, 100177, 100181, 100201, 100219, 100473, 100504, 100539 |
| Model numbers | 10592457 |
Product
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Reason for recall
Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
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-1975-2013. 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.