BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XORAN

    MDR report key: 2088163 · Received May 9, 2011

    Report

    Report Number
    MW5020541
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    November 7, 2012
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) WILL NOT COMPLY WITH A REQUEST FOR INFORMATION PURSUANT TO 21CFR (B)(4) FOR THE MINICAT CT SCANNER, K032243. (B)(6) ALSO HAS REMOVED THE DISK DRIVES FROM A MINICAT SYSTEM MAKING THAT SYSTEM UNABLE TO PERFORM AS IT IS INTENDED TO DO.

    Description of Event or Problem · 1

    (B)(4). STATUS: ACTIVE DATE OF REGISTRATION STATUS: 2012. REFUSES TO COMPLY WITH A REQUEST FOR INSTRUCTIONS COMPLIANT WITH 21CFR 1020.30, 1020.33 AND 820.170. THIS HAS BEEN REPORTED PREVIOUSLY, BUT NO ACTION HAS BEEN TAKEN BY CDRH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XORAN MINICAT DENTOCAT JAK XORAN TECHNOLOGIES, INC. 9170-0000-0000F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MINICAT CT SCANNER