Siemens syngo — Class II medical device recall Z-0271-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-11-20, distributed nationwide. The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cau
| Recall number | Z-0271-2014 |
|---|---|
| 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 | 2011-08-08 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 19 |
| Serial numbers | 100005, 100006, 100007, 100008, 100009, 100010, 100138, 100146, 100157, 100174, 100177, 100181, 100198, 100201, 100219, 100249, 100263, 100301, 100302 |
| Model numbers | 10592457 |
Product
Siemens syngo.plaza image processing system image processing radiological system
Reason for recall
The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.
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-0271-2014. 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.