Syngo Dynamics v9 — Class II medical device recall Z-1613-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-05-21, distributed nationwide. Systems with the affected serial number are experiencing a software error which may lead to incorrect patient
| Recall number | Z-1613-2014 |
|---|---|
| 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 | 2014-04-03 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2014-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Reason classes | software |
| Serial numbers | 85019, 85062, 85067, 85068, 85080, 85114, 85115, 85123, 85130, 85134, 85151, 85157, 85163, 85165, 85168, 85170, 85177, 85178, 85188, 85191, 85192, 85194, 85195, 85198, 85199 and 25 more |
| Model numbers | 10091673, 10091805, 10091806, 10091807 |
Product
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
Reason for recall
Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
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-1613-2014. 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.