BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALI ULTRAPACS GX V3.2 MEDICAL IMAGE VIEWER

    MDR report key: 437429 · Received January 9, 2003

    Report

    Report Number
    8022257-2002-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2003
    Report Date
    November 6, 2001
    Manufacturer
    A.L.I. TECHNOLOGIES, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN OBSERVED THAT IN USING THE 3D TOOL FEATURE IN ALI ULTRAPACS GX V3.2, THE ANATOMICAL LABELS "LEFT" AND "RIGHT" WERE SWITCHED IN A 3D REPRESENTATION OF A SAGGITAL SERIES OF IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALI ULTRAPACS GX V3.2 MEDICAL IMAGE VIEWER PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (PACS) LNX A.L.I. TECHNOLOGIES, INC. GX V3.2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *