BEUDAMED
    FDA Recall 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 · Initiated August 30, 2019

    Recall

    Recall Number
    Z-2261-2020
    Event Number
    85325
    Firm
    Spacelabs Healthcare, Inc.
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    August 30, 2019
    Terminated
    April 18, 2024
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    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.

    Action

    Urgent Medical Device Correction letters were sent to U.S. customers on August 30, 2019 via priority service, and to foreign customers via email on September 6, 2019. The letter informed customers of the conditions under which alarm audio may be lost, and actions the customer /user can take to minimize risk to patients or users. Customers were requested to weigh the benefits versus the risks when deciding whether or not to continue to use Xhibit Central with software versions 1.3.1, 1.3.2, 1.3.3, and 1.3.4. Customers experiencing a loss of audio were informed that a complete reboot of the Xhibit Central will return the device to normal operation. Customers were requested to circulate this notification to all persons affected by the information it contains. Customers were also informed that the manufacturer would contact them to schedule a time for Spacelabs to update their Xhibit Central software. Customers with questions, requiring information, or technical assistance may contact the Technical Support group at Spacelabs Healthcare, Inc. at 1-800-522-7025 and select 2 for Technical Support.

    Distribution

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

    Quantity

    2197 units