syngo Imaging XS. Radiological image processing system recall
syngo Imaging XS. Radiological image processing system.
Why was syngo Imaging XS. Radiological image processing system 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".
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model number 10496279
- Product
- syngo Imaging XS. Radiological image processing system.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 52
- Distribution
- 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.
- Recall date
- September 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)