Siemens syngo — Class II medical device recall Z-2078-2012
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-08-01, distributed nationwide. Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For d
| Recall number | Z-2078-2012 |
|---|---|
| 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 | 2012-02-24 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2014-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | device malfunction, software |
| Model numbers | 10592457 |
Product
Siemens syngo.plaza. Radiological image processing system
Reason for recall
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
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-2078-2012. 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.