BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISAGE 7

    MDR report key: 2594443 · Received December 22, 2010

    Report

    Report Number
    9616251-2010-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    VISAGE IMAGING GMBH
    Product Code
    LLZ
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR CONTINUOUS INTERNAL QUALITY CONTROL AND IMPROVEMENT PROCESS FOR THE VISAGE 7 SOFTWARE WE HAVE FOUND THAT TWO OF THE SPECIALIZED 2D MEASUREMENT TOOLS IN SOME SITUATIONS DO NOT ALLOW FOR MANUAL PIXEL SIZE CALIBRATION AND CAN LEAD TO MISLEADING RESULTS IF USED IN COMBINATION WITH THE MANUAL SIZE CALIBRATION TOOL. THE AFFECTED TOOLS ARE THE SPECIALIZED VERTICAL DISTANCE MEASUREMENT TOOL (USED BY SOME CUSTOMERS FOR HIP TILT MEASUREMENT) AND THE 2D FREEHAND ROI TOOL.

    Description of Event or Problem · 1

    AS PART OF OUR CONTINUOUS INTERNAL QUALITY CONTROL AND IMPROVEMENT PROCESS FOR THE VISAGE 7 SOFTWARE WE HAVE FOUND THAT TWO OF THE SPECIALIZED 2D MEASUREMENT TOOLS IN SOME SITUATIONS DO NOT ALLOW FOR MANUAL PIXEL SIZE CALIBRATION AND CAN LEAD TO MISLEADING RESULTS IF USED IN COMBINATION WITH THE MANUAL SIZE CALIBRATION TOOLS. THE AFFECTED TOOLS ARE THE SPECIALIZED VERTICAL DISTANCE MEASUREMENT TOOL (USED BY SOME CUSTOMERS FOR HIP TILT MEASUREMENT), AND THE 2D FREEHAND RIO TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISAGE 7 PICTURE ARCHIVING A. COMMUNICATION SYSTEM LLZ VISAGE IMAGING GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1