BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

    Recall: Z-0532-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0532-2018
    Event ID
    78989
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    January 17, 2018
    Classification Date
    February 5, 2018
    Termination Date
    November 29, 2018
    Address
    35301 SE Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

    Reason

    Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

    Code Info

    Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290

    Distribution

    US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France

    Quantity

    12 systems