BEUDAMED
    FDA Enforcement Class II Terminated

    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

    Recall: Z-2584-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2584-2021
    Event ID
    88661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 25, 2021
    Classification Date
    September 28, 2021
    Termination Date
    April 30, 2024
    Address
    5101 Shady Oak Rd S, N/A, Minnetonka, MN, 55343-4100, United States

    Description

    Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.

    Reason

    ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

    Code Info

    UDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); Model Number: 113821-600 (Serial Numbers: 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754); Model Number: 114148-000 (Serial Numbers: 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997)

    Distribution

    Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.

    Quantity

    13 units