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U.S. Department of Health and Human Services

Class 2 Device Recall System, Image Processing Radiological

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  Class 2 Device Recall System, Image Processing Radiological see related information
Date Initiated by Firm February 24, 2016
Date Posted March 23, 2016
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-1232-2016
Recall Event ID 73481
510(K)Number K143319  
Product Classification System, image processing, radiological - Product Code LLZ
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.
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Code Information Serial # 20119, 20098, 20041, 20124, 12177, 20026
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.
FDA Determined
Cause 2		 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 in Commerce 6
Distribution Nationwide Distribution to IL, NY, MT, and MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Siemens Medical Solutions, Inc
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