Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | syngo Imaging XS. Radiological image processing system. |
|---|---|
| Recall Number | Z-2264-2012 |
| Classification | Class II |
| Code Info | Model number 10496279 |
| Product Distributed Qty | 52 |
| Reason For Recall | 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". |
Event Detail
| Event Id | 62678 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| City | Malvern |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-18 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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