BEUDAMED
    FDA Recall Terminated

    Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027

    Recall: Z-0660-2008 · Initiated October 8, 2007

    Recall

    Recall Number
    Z-0660-2008
    Event Number
    44965
    Firm
    Spacelabs Healthcare, Incorporated
    FEI Number
    3010157426
    Product Code
    CBR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 8, 2007
    Posted
    January 31, 2008
    Terminated
    April 12, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027

    Reason

    Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

    Action

    The firm sent out their Urgent Medical Device correction/recall letters on 10/5/2007, and an updated versions on 11/30/07 and 12/7/2007, forwarding an attached set of work around directions for use and associated tables for calculations. This short term fix will be updated to a permanent fix when a new software revision is released and installed at no cost to each user as noted in the recall notification. Telephone contact was provided at 1-800-522-7025.

    Distribution

    Worldwide

    Quantity

    722 devices