BEUDAMED
    FDA Enforcement Class II Ongoing

    AxiEM" Non-Invasive Patient Tracker

    Recall: Z-1039-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1039-2023
    Event ID
    91354
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 8, 2023
    Initiation Date
    December 15, 2022
    Classification Date
    January 30, 2023
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    AxiEM" Non-Invasive Patient Tracker

    Reason

    Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.

    Code Info

    Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00763000588380 Lot Number: 220728I 220729 Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00643169608252 Lot Number: 220728I

    Distribution

    Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of Japan.

    Quantity

    1,867 devies