BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

    Recall: Z-2077-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2077-2014
    Event ID
    68611
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    June 18, 2014
    Classification Date
    July 17, 2014
    Termination Date
    December 8, 2014
    Address
    35301 SE Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    Description

    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

    Reason

    With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

    Code Info

    Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209

    Distribution

    Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.

    Quantity

    8 units total (3 units in US)