Class 2 Device Recall Siemens

• Date Initiated by Firm: June 30, 2014
• Date Posted: July 23, 2014
• Recall Status: Terminated on February 24, 2015
• Recall Number: Z-2111-2014
• Recall Event ID: 68769
• 510(K)Number: K082430
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
• Code Information: model number: 10496279
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Customer Support; 610-219-6300
• Manufacturer Reason for Recall: Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge enhancement and Histograms . This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d
• FDA Determined Cause: Software design
• Action: Siemens sent a Customer letter dated June 30th, to all affected customers to inform them of a new software version VA70B_0114 that will be introduced to all syngo Imaging XS customers with version VA70A or higher to solve a potential issue regarding miscalculations done for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement", and "Histograms". For questions regarding this recall call 610-219-6300.
• Quantity in Commerce: 141
• Distribution: Nationwide Distribution
• 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