syngo — Class II medical device recall Z-2275-2012
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2012-09-05, distributed nationwide. There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater t
| Recall number | Z-2275-2012 |
|---|---|
| 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 | 2012-07-18 |
| Classified | 2012-08-27 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2014-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 14 |
| Reason classes | device malfunction |
| Serial numbers | 100138, 100146, 100174, 100177, 100181, 100198, 100201, 100219, 100249, 100263, 100301, 100401, 100406, 200040 |
| Model numbers | 10592457 |
Product
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Reason for recall
There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
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-2275-2012. 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.