syngo Dynamics Picture Archiving and Communication System — Class II medical device recall Z-1216-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-03-26, distributed nationwide. Potential patient data mixup. Improper error handling could allow for two different patients to be displayed i
| Recall number | Z-1216-2014 |
|---|---|
| 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 | 2014-01-27 |
| Classified | 2014-03-18 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Model numbers | 10091673, 10091804, 10091805, 10091806, 10091807, S.10091804 |
Product
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Reason for recall
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
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-1216-2014. 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.