FDA Device recall Z-1232-2016
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medic…
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medic… by Siemens Medical Solutions Usa, citing after importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1232-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-24 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Identifiers
| code_info | Serial # 20119, 20098, 20041, 20124, 12177, 20026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1232-2016%22
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