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Terminated

syngo Imaging XS. Radiological image processing system.

FDA Recall Z-2264-2012 · Posted 2012-08-24

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-07-18
Date Terminated2014-11-06
Product Quantity52

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".

Firm Action

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..

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082430SYNGO IMAGING XSSiemens AG Medical Solutions · 2008-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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