BEUDAMED
    FDA Enforcement Class II Terminated

    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.

    Recall: Z-0806-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0806-2020
    Event ID
    84616
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    January 6, 2020
    Classification Date
    January 13, 2020
    Termination Date
    May 29, 2020
    Address
    1049 W Ridge Rd, Rochester, NY, 14615-2731, United States

    Description

    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.

    Reason

    Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

    Code Info

    DR3000: 6551360, 6551386, 6551345, 6552160, 6552152, 6551394 DR3500: 6553101, 6553127, 6553119, 6553143, 6553135, 6553036, 6553093

    Distribution

    Worldwide distribution in the sate of Iowa and countries of Italy, China, Spain, and Austria.

    Quantity

    79