Recalls / —
—#111340
Product
syngo Imaging XS. Radiological image processing system.
- FDA product code
- LLZ — System, Image Processing, Radiological
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K082430
- Affected lot / code info
- Model number 10496279
Why it was recalled
There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
Root cause (FDA determination)
Software design
Action the firm took
Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
Timeline
- Recall initiated
- 2012-07-18
- Posted by FDA
- 2012-08-24
- Terminated
- 2014-11-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #111340. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.