BEUDAMED
    FDA Recall 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 · Initiated June 18, 2014

    Recall

    Recall Number
    Z-2077-2014
    Event Number
    68611
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    CBR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 18, 2014
    Posted
    July 17, 2014
    Terminated
    December 8, 2014
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    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.

    Action

    Spacelabs sent an Urgent Medical Device Correction letter dated June 20, 20/14 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers are informed that Spacelabs Field Service personnel will be contacting their facility to schedule a convenient time to confirm, at no cost, a software update is needed to resolve this issue. Customers with questions are instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

    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)