BEUDAMED
    FDA Recall Terminated

    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

    Recall: Z-0480-2016 · Initiated December 4, 2015

    Recall

    Recall Number
    Z-0480-2016
    Event Number
    72747
    Firm
    Synaptive Medical, Inc.
    FEI Number
    3012075008
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 4, 2015
    Posted
    December 23, 2015
    Terminated
    March 4, 2016
    Address
    101 College Street, MaRS Centre, South Tower Toronto Canada Suite 200

    Description

    Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

    Reason

    Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.

    Action

    Consignees were sent via courier on 12/4/2015 a Synaptive "Urgent Medical Device Recall" letter dated 30 November 2015. The letter described the problem and the device involved in the recall. Informed consignees that a technical support team member from Synaptive Medical will conduct the field correction. They also requested consignees to complete and return the Recall Response Form. For questions contact Thas Yuwaraj, PhD, .PEng Monday through Friday, 9 AM to 5 PM, Eastern Time at 1-844-462-7246.

    Distribution

    US: FL, WI, IL, LA, WA.

    Quantity

    8