BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALI ULTRAPACS GX V3.2 MEDICAL IMAGE VIEWER

    MDR report key: 438012 · Received January 9, 2003

    Report

    Report Number
    8022257-2002-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2003
    Report Date
    July 19, 2002
    Manufacturer
    A.L.I. TECHNOLOGIES, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINICAL SITE OBSERVED THAT IMAGES ACQUIRED FROM A PARTICLAR GENERAL ELECTRIC CT SCANNER WERE BEING DISPLAYED USING THE ALI ULTRAPACS GX V3.2 MEDICAL IMAGE VIEWING SOFTWARE IN THE EXPECTED CLINICAL ORIENTATION HOWEVER WHEN PRINTED THE IMAGES WERE "FLIPPED' RIGHT TO LEFT. ON THE DISPLAY AND ON THE PRINTED HARDCOPY, THE ANATOMICAL MARKERS DID IDENTIFY THE CORRECT SIDE OF THE PT (I.E. A "R" MARKER CORRECTLY APPEARED ADJACENT TO THE PT'S RIGHT SIDE).

    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 VERSION 3.2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *