syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, a
FDA device recall Z-1232-2016 · posted 2016-03-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6
- Distribution
- Nationwide Distribution to IL, NY, MT, and MN.
- Date initiated
- 2016-02-24
- Date posted
- 2016-03-23
- Date terminated
- 2017-02-16
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Syngo X-workplace SW VD10 (K143319) | Siemens Medi Cal Solutions, Inc. | 2015-02-24 |