BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare DuraDiagnost stationary X-ray system

    Recall: Z-1696-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1696-2016
    Event ID
    74083
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    November 10, 2015
    Classification Date
    June 3, 2016
    Termination Date
    May 3, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    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.

    Code Info

    software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

    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