Recall Z-1232-2016— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-02-24, terminated 2017-02-16. It names one FDA 510(k) clearance: K143319. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-24
- Terminated
- 2017-02-16
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.