BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0194-2018 · Initiated October 5, 2017

    Recall

    Recall Number
    Z-0194-2018
    Event Number
    78315
    Firm
    Monteris Medical Corp
    FEI Number
    3009970070
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 5, 2017
    Posted
    March 20, 2018
    Terminated
    January 21, 2021
    Address
    14755 27th Ave N, Ste C, Plymouth, MN, 55447-4866

    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.

    Action

    The firm issued advisory notice 10/05/2017. The notice discussed complaints received that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.5T) MRI systems. The notice provided added recommendations for all NeuroBlate users to mitigate the anomaly.

    Distribution

    Nationwide and Canada

    Quantity

    52 systems