BEUDAMED
    FDA Recall Terminated

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    Recall: Z-1394-2022 · Initiated December 4, 2018

    Recall

    Recall Number
    Z-1394-2022
    Event Number
    90448
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FQA
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    December 4, 2018
    Terminated
    March 11, 2024
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    Reason

    Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.

    Action

    Gauss notified customers with a notification letter dated Dec 4, 2018. The letter informed customers that the IFU would be updated in order to clarify proper technique for handling sponges and the calibration placard. No action was required by the customer as the IFU updates were automatically accessible to the user through the iPad application and automatically moved to the newest revision.

    Distribution

    US Nationwide.

    Quantity

    51 units