BEUDAMED
    FDA Enforcement Class II Ongoing

    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

    Recall: Z-0809-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0809-2025
    Event ID
    95927
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2025
    Initiation Date
    November 25, 2024
    Classification Date
    January 7, 2025
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

    Reason

    Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.

    Code Info

    Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246

    Distribution

    US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech Republic

    Quantity

    2265