Syngo — Class II medical device recall Z-0576-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-12-17, distributed nationwide. Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming appli
| Recall number | Z-0576-2015 |
|---|---|
| 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 | 2014-11-11 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 149 |
| Serial numbers | 100025, 100027, 100029, 100031, 100033, 100084, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100132, 100133 and 121 more |
| Model numbers | 10496279, 10592457, 10863171, 10863172, 10863173, 7502029 |
Product
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Reason for recall
Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.
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-0576-2015. 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.