software for Syngo Dynamics a Picture Archiving and Communication… — Class II medical device recall Z-0826-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-03-02, distributed nationwide. Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare
| Recall number | Z-0826-2016 |
|---|---|
| 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 | 2016-01-29 |
| Classified | 2016-02-19 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 151 |
| Reason classes | software |
| Model numbers | 10091673 |
Product
software for Syngo Dynamics 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. Syngo Dynamics is not intended to be used for reading of mammography images.
Reason for recall
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
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-0826-2016. 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.