BEUDAMED
    FDA Recall Terminated

    Philips Healthcare DuraDiagnost stationary X-ray system

    Recall: Z-1696-2016 · Initiated November 10, 2015

    Recall

    Recall Number
    Z-1696-2016
    Event Number
    74083
    Firm
    Philips Healthcare
    FEI Number
    1218950
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 10, 2015
    Posted
    June 3, 2016
    Terminated
    May 3, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Healthcare DuraDiagnost stationary X-ray system

    Reason

    The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

    Action

    Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 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 1-800- 722-9377.

    Distribution

    USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

    Quantity

    5