BEUDAMED
    FDA Recall Terminated

    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.

    Recall: Z-2129-2016 · Initiated June 20, 2016

    Recall

    Recall Number
    Z-2129-2016
    Event Number
    74464
    Firm
    Medtronic Navigation Kochav Yokneam 1 Hamelacha St. Yokne'am Ilit Israel
    FEI Number
    3003348378
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 20, 2016
    Posted
    July 6, 2016
    Terminated
    June 21, 2017

    Description

    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.

    Reason

    Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.

    Action

    Medtronic sent a Field Safety Notice letter dated August 1, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Medtronic will perform an inspection on site to verify and correct the grounding connection of the PoleStar System. For questions contact Medtronic Navigation Technical Services at 1-800-595-9709.

    Distribution

    Worldwide Distribution - US Nationwide.

    Quantity

    52