BEUDAMED
    FDA Recall 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 · Initiated January 17, 2018

    Recall

    Recall Number
    Z-0532-2018
    Event Number
    78989
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    MSX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 17, 2018
    Posted
    January 25, 2018
    Terminated
    November 29, 2018
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    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.

    Action

    On January , 2018, a customer letter was sent via priority service, return receipt requested, to all U.S. customers. International consignees will be notified on January 24 , 2018, by email. The letter stated: " Please weigh the benefits versus the risks when deciding whether or not to continue to use your Exhibit Telemetry Receiver(s) until updated as set forth below. We recommend that you brief your staff regarding the failure mode listed above." Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to update your Exhibit Telemetry Receiver(s) to software version 1.0.2 at no cost." For further questions, please call (800) 522-7025.

    Distribution

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

    Quantity

    12 systems