BEUDAMED
    FDA Recall Terminated

    TCM CombiM Modules 903-111

    Recall: Z-1595-2016 · Initiated November 18, 2015

    Recall

    Recall Number
    Z-1595-2016
    Event Number
    73601
    Firm
    Radiometer America Inc
    FEI Number
    3010420736
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 18, 2015
    Terminated
    March 27, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    TCM CombiM Modules 903-111

    Reason

    Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

    Action

    RadioMeter sent an Product Notification letter out on November 18, 2015, January 10, 2016 and March 29, 2016. The notification sent on November 18, 2015 and January 10, 2016, instructed customers a temporary solution of switching off the analyzer and then on again in order to re-establish the pre-set alarm volume. If alarm sound is higher than the pre-set volume customers are instructed to contact their local Radiometer service representative. If any questions contact Radiometer America Technical Support at 1-800-736--600 opt. 4. The notification sent on March 29, 2016, provided the same instructions and temporary solution. The notification also informed customers that the firm will be in contact with them to discuss the upgrade process.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of : MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of : Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.

    Quantity

    1488