BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISEPLAN 2.15

    MDR report key: 962408 · Received May 4, 2007

    Report

    Report Number
    9617016-2007-00018
    Event Type
    Malfunction
    Date Received
    May 4, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 4, 2007
    Manufacturer
    ELEKTA, LTD
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEW PIB EXPRESS APPLICATION IN PRECISEPLAN ONLY WORKS CORRECTLY WITH SPECIFIC DICOM INPUT PARAMETERS. THE EFFECTIVE RESULT IS THAT FOR SOME CT SCANNER INPUTS, THE PIB EXPRESS APPLICATION WILL WORK CORRECTLY, HOWEVER, FOR SOME SCANNERS THE PIB EXPRESS APPLICATION WILL CREATE A SMALL ERROR AND OTHER SCANNERS WILL GIVE INACCURATE ANSWERS. AN IMPORTANT NOTICE IS IN THE PROCESS OF BEING DRAFTED AND RELEASED TO THE APPROPRIATE CUSTOMER'S AFFECTED.

    Description of Event or Problem · 1

    PIB FILES CREATED WITH PIB EXPRESS WILL HAVE INCORRECT HOUNSFIELD AND DENSITY INFO WHEN USING CT DICOM IMAGE FILES WHICH DO NOT HAVE EXPECTED PARAMETER VALUES. (R2.15).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISEPLAN 2.15 * MUJ ELEKTA, LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *