BEUDAMED
    FDA Recall Terminated

    Sedecal SA Mobile Diagnost w DR x-ray system

    Recall: Z-1691-2016 · Initiated March 23, 2015

    Recall

    Recall Number
    Z-1691-2016
    Event Number
    74106
    Firm
    Sedecal USA, Inc.
    FEI Number
    1000139935
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 23, 2015
    Terminated
    March 9, 2018
    Address
    230 Lexington Dr, Buffalo Grove, IL, 60089-6930

    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.

    Action

    Sedecal USA has developed a new software release to address this issue. The distributor of this product, Philip, will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the two defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (847) 394-6960.

    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