BEUDAMED
    FDA Recall Open, Classified

    Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

    Recall: Z-2474-2020 · Initiated June 2, 2020

    Recall

    Recall Number
    Z-2474-2020
    Event Number
    85782
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    MVR
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 2, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

    Reason

    A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

    Action

    Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., sent a notification to healthcare providers dated, June 2, 2020 titled, "Urgent Medical Device Recall". The notification was sent to the user level for the GEM1020M-2 Flow Coupler Monitor due to a firmware issue which may cause the monitor to intermittently shut down when a WiFi connection is not established. If a shutdown occurs, the monitor can be manually powered back on and will resume normal operation. Synovis is requesting the return of the monitors to perform a firmware upgrade to resolve the issue. Customers should contact Synovis to arrange for product return for the firmware upgrade and replacement of the product. Customers should complete the Baxter customer reply form and return it to Baxter by scanning and e-mailing it to [email protected], even if customers do not have any inventory. Customers should return the response form promptly. If customers have distributed the product to other facilities or departments within the institution, a copy of the communication should be forwarded to them. Questions regarding the communication, contact Synovis at 800-510-3318 or 205-941-0111, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.

    Distribution

    U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.

    Quantity

    60 units