syngo Dynamics Information System — Class II medical device recall Z-1859-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-08-07, distributed in CA, MO, NY, OH, PA, TX, UT. Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics
| Recall number | Z-1859-2013 |
|---|---|
| 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 | 2013-06-10 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2015-02-24 |
| Distributed | CA, MO, NY, OH, PA, TX, UT |
| Quantity | 9 |
| Serial numbers | 85051, 85116, 85149, 85164, 85177, 85278, 85289, 85296, 85297 |
| Model numbers | 10091637, 10091805 |
Product
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammography images.
Reason for recall
Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
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-1859-2013. 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.