BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS MR/X-ray head fixation device, Model HFD200

    Recall: Z-0163-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0163-2020
    Event ID
    83278
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    June 26, 2019
    Classification Date
    October 18, 2019
    Termination Date
    October 29, 2020
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS MR/X-ray head fixation device, Model HFD200

    Reason

    Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.

    Code Info

    HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448

    Distribution

    TN, NH, FL

    Quantity

    3 units