BEUDAMED
    FDA Recall Terminated

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    Recall: Z-0227-2015 · Initiated October 3, 2014

    Recall

    Recall Number
    Z-0227-2015
    Event Number
    69514
    Firm
    Monteris Medical Corp
    FEI Number
    3009970070
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 3, 2014
    Posted
    November 19, 2014
    Terminated
    December 8, 2014
    Address
    16305 36th Ave N, Suite 200, Plymouth, MN, 55446-2884

    Description

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    Reason

    Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

    Action

    Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by user: Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment. Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.

    Distribution

    US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA

    Quantity

    234 devices