BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0163-2020 · Initiated June 26, 2019

    Recall

    Recall Number
    Z-0163-2020
    Event Number
    83278
    Firm
    Deerfield Imaging, Inc.
    FEI Number
    3010326005
    Product Code
    HBL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 26, 2019
    Terminated
    October 29, 2020
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100

    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.

    Action

    The firm disseminated a field safety notice on 06/26/2019 by letter. The notice explained the problem and requested that the consignee inspect the skull clamp prior to use and be aware that overtightening of the drive knob may result in failure. The drive knobs will be replaced with an updated design when available.

    Distribution

    TN, NH, FL

    Quantity

    3 units