BEUDAMED
    FDA Recall Open, Classified

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    Recall: Z-1012-2022 · Initiated March 4, 2022

    Recall

    Recall Number
    Z-1012-2022
    Event Number
    89877
    Firm
    Draegar Medical Systems, Inc.
    FEI Number
    3005783425
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 4, 2022
    Address
    6 Tech Dr, Andover, MA, 01810-2434

    Description

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    Reason

    Software issue resulting in temporary loss of central monitoring functionality.

    Action

    A notification signed 03/08/2022, issued via certified mail on 03/11/2022 and 03/24/2022, notified customers of the impacted software versions, that a software update will be deployed to correct the issue, and provided interim instructions regarding use of USB devices. Customers are to notify all users and return the acknowledgement form. For questions please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.

    Quantity

    1950 (1574 OUS + 376 US)