Recall Z-1232-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
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. .
| Date | Mar 23, 2016 (initiated Feb 24, 2016) |
| Status | Terminated |
| Reason | After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure. |
| Root cause | Software design |
| Action | Siemens sent an Important Customer Safety Notice dated February 24, 2016, to all affected customers notifying them that the issue will be remedied with a software update via AX004/16/S. Following the installation of this update, the segmentation results can be used at the CARTO system as described in the operator manual. Customers with questions were instructed to call 800-888-7436. For questions regarding this recall call 610-448-6461. |
| Quantity | 6 |
| Distribution | Nationwide Distribution to IL, NY, MT, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143319 | Syngo X-workplace SW VD10 Siemens Medi Cal Solutions, Inc., Feb 24, 2015 |