BEUDAMED
    FDA Recall Terminated

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    Recall: Z-2203-2008 · Initiated June 24, 2008

    Recall

    Recall Number
    Z-2203-2008
    Event Number
    48666
    Firm
    CAS Medical Systems, Inc.
    FEI Number
    2244861
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    June 24, 2008
    Posted
    September 16, 2008
    Terminated
    August 5, 2010
    Address
    44 E Industrial Rd, Branford, CT, 06405-6507

    Description

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    Reason

    Software: Audible alarm may be silenced if changed from the factory setting

    Action

    CASMED notified customers by a Product Correction Notification letter on 6/24/08 to advise of problem of the audible alarm and a software upgrade to correct the problem. The firm requests that the alarm volume not be adjusted from its factory set value to ensure that alarms sound correctly. Also, the letter states that if the volume needs to be adjusted, that customers needs to be sure that they only select two clicks above, or two clicks below the mid-point, and that there is a corresponding beep when you make your selection. Customers are asked to review the attached list of serial numbers that will need to be updated with new software and to then email the a contact at the firm once updates have been completed. All updates must be completed by August 31, 2008.

    Distribution

    Worldwide Distribution --- including USA and countries of Canada, Jordan, UK, France, and Taipei.

    Quantity

    820 units