Recalls / —
—#144271
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. .
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K143319
- Affected lot / code info
- Serial # 20119, 20098, 20041, 20124, 12177, 20026
Why it was recalled
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- Nationwide Distribution to IL, NY, MT, and MN.
Timeline
- Recall initiated
- 2016-02-24
- Posted by FDA
- 2016-03-23
- Terminated
- 2017-02-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.