BEUDAMED
    FDA Recall Terminated

    Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0

    Recall: Z-1023-04 · Initiated May 24, 2004

    Recall

    Recall Number
    Z-1023-04
    Event Number
    29223
    Firm
    CAS Medical Systems, Inc.
    FEI Number
    2244861
    Product Code
    BZQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2004
    Posted
    July 20, 2004
    Terminated
    June 13, 2005
    Address
    44 E Industrial Rd, Branford, CT, 06405-6507

    Description

    Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0

    Reason

    Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

    Action

    CAS Medical notified customers by telephone and followed with letter dated 5/24/04, advising users of the problem and to turn off the StatsSeconds feature.

    Distribution

    CA, DC, IL, IN, GA, ME, MI, MN, NH, NJ, NY, PA, TX, WV. Foreign: Canada, Taiwan

    Quantity

    146 units