Day

March 28, 2008
Company: Ventana Image Analysis System (VIAS), Date of Enforcement Report 3/26/2008 Class:ll PRODUCT Ventana Image Analysis System (VIAS) – PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Recall # Z-0571-2008 REASON Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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