BEUDAMED
    FDA Enforcement Class II Terminated

    Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    Recall: Z-2261-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2261-2020
    Event ID
    85325
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 10, 2020
    Initiation Date
    August 30, 2019
    Classification Date
    June 4, 2020
    Termination Date
    April 18, 2024
    Address
    35301 Se Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    Description

    Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

    Reason

    The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

    Code Info

    Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345

    Distribution

    Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.

    Quantity

    2197 units