BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0810-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0810-2025
    Event ID
    95910
    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 with Software, Model 96280. Intended to provide monitoring system with patient data.

    Reason

    Telemetry receivers with affected software versions may experience unsolicited system 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 and necessary clinical intervention could be delayed.

    Code Info

    Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246

    Distribution

    US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.

    Quantity

    434