BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISAGE PACS 6.0/CS3.1

    MDR report key: 2651321 · Received March 2, 2009

    Report

    Report Number
    9616251-2009-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 27, 2009
    Manufacturer
    VISAGE IMAGING GMBH
    Product Code
    LLZ
    PMA / PMN Number
    K082269
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN APPLYING THE ROI TOOL IN A VIEWER WHERE THE DISPLAYED SLICE THICKNESS IS LARGER THAN THE ORIGINAL SLICE THICKNESS, THE CALCULATED STATISTICAL VALUES MAY APPEAR TO NOT MATCH THE VISUAL IMPRESSION, BECAUSE SUCH CALCULATIONS ARE ALWAYS PERFORMED BASED ON THE ORIGINAL SLICE THICKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISAGE PACS 6.0/CS3.1 VISAGE CS 3.1 LLZ VISAGE IMAGING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 N.A.