BEUDAMED
    FDA Recall Terminated

    IMRIS ORT100 Table, Part Number 110470-000

    Recall: Z-0975-2018 · Initiated February 20, 2018

    Recall

    Recall Number
    Z-0975-2018
    Event Number
    79360
    Firm
    Deerfield Imaging, Inc.
    FEI Number
    3010326005
    Product Code
    KXJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 20, 2018
    Terminated
    August 27, 2019
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100

    Description

    IMRIS ORT100 Table, Part Number 110470-000

    Reason

    The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.

    Action

    The firm disseminated the notices on 02/23/2018 and followed with emails on 02/26/2018. The notices stated: "To minimize the risk of injury, IMRIS is taking the following corrective actions: " ORT100 Table: The rotational locking mechanism shall be replaced in all ORT100 tables that do not contain the most current design. " T2X Table: Tables will have their rotational lock inspected. If components are worn or performance is other than intended, the rotational lock assembly will be serviced or replaced entirely. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS.IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, back section, headrest, pendant connection and swivel release pedal free engagement " During usage, verify the table is locked by manually pushing the table to make sure it does not move rotationally. " If the rotational lock is observed to be not functioning properly, please contact IMRIS Customer Service. The appropriate competent authorities have been notified of this corrective action. IMRIS is committed to patient and user safety, and apologizes for any inconvenience that this may cause. Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@i mris.com if you have any questions or concerns."

    Distribution

    US, Canada, Australia, China, Qatar

    Quantity

    15 tables