BEUDAMED
    FDA Recall Terminated

    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

    Recall: Z-0167-2018 · Initiated July 20, 2016

    Recall

    Recall Number
    Z-0167-2018
    Event Number
    78367
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 20, 2016
    Terminated
    June 16, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.

    Reason

    Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.

    Action

    This is a retrospective report of a correction initiated on 20-Jul-2016. Customers were informed onsite by field Service Technicians of the planned correction. The software issue described was corrected in the new software version ROSA Brain 3.0.0.20. Field Service Technicians were deployed to the customers locations to perform the system upgrade. .

    Distribution

    Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France

    Quantity

    18 (14 US and 4 OUS)