BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOSCAN TRUE VIEW DIGITAL MAMMOGRAPHY SYSTEM

    MDR report key: 599739 · Received April 27, 2005

    Report

    Report Number
    1418957-2005-00004
    Event Type
    Malfunction
    Date Received
    April 27, 2005
    Date of Event
    May 4, 2004
    Report Date
    April 27, 2005
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMAGE PROCESSING ALGORITHM USED IN SENOSCAN SW VERSIONS 4.0.7, 4.0.8 OR 4.0.9.1 CAN POTENTIALLY ELIMINATE BREAST TISSUE CLOSE TO THE SKIN LINE IF THE TISSUE IS DENSE. THREE COMPLAINTS HAVE BEEN RECEIVED BY FISCHER IMAGING REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOSCAN TRUE VIEW DIGITAL MAMMOGRAPHY SYSTEM MAMMOGRAPHY EQUIPMENT IZH FISCHER IMAGING CORP. 94829G-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *