BEUDAMED
    FDA Enforcement Class I Terminated

    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.

    Recall: Z-0194-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-0194-2018
    Event ID
    78315
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Monteris Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    October 5, 2017
    Classification Date
    March 20, 2018
    Termination Date
    January 21, 2021
    Address
    14755 27th Ave N Ste C, N/A, Plymouth, MN, 55447-4866, United States

    Description

    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.

    Reason

    The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.

    Code Info

    All serial numbers

    Distribution

    Nationwide and Canada

    Quantity

    52 systems