syngo X Workplace is a medical workstation for real-time viewing — Class II medical device recall Z-1232-2016
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-03-30, distributed nationwide. After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablati
| Recall number | Z-1232-2016 |
|---|---|
| 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 | 2016-02-24 |
| Classified | 2016-03-23 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 6 |
| Serial numbers | 12177, 20026, 20041, 20098, 20119, 20124 |
Product
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
Reason for recall
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
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-1232-2016. 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.