BEUDAMED
    FDA Enforcement Class II Ongoing

    E3800 PC Units (spare parts)

    Recall: Z-1858-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1858-2021
    Event ID
    87870
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    April 14, 2021
    Classification Date
    June 15, 2021
    Address
    Akandevej 21, Bronshoj, N/A, Denmark

    Description

    E3800 PC Units (spare parts)

    Reason

    Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

    Code Info

    Part number: 910-414

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.

    Quantity

    Total 965 PC units World-wide (only 35 units in the U.S.)