BEUDAMED
    FDA Enforcement Class II Terminated

    Sedecal SA Mobile Diagnost w DR x-ray system

    Recall: Z-1691-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1691-2016
    Event ID
    74106
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sedecal USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    March 23, 2015
    Classification Date
    June 3, 2016
    Termination Date
    March 9, 2018
    Address
    230 Lexington Dr, N/A, Buffalo Grove, IL, 60089-6930, United States

    Description

    Sedecal SA Mobile Diagnost w DR x-ray system

    Reason

    Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface.

    Code Info

    System Code 712001

    Distribution

    US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.

    Quantity

    US - 145