BEUDAMED
    FDA Enforcement Class II Terminated

    TCM CombiM Modules 903-111

    Recall: Z-1595-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1595-2016
    Event ID
    73601
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    November 18, 2015
    Classification Date
    May 2, 2016
    Termination Date
    March 27, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    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.

    Code Info

    Part Number: 903-111 Lot Number: Below R0174

    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