BEUDAMED
    FDA Enforcement Class II Ongoing

    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

    Recall: Z-1074-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1074-2022
    Event ID
    89990
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Daavlin Distributing Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 18, 2022
    Initiation Date
    April 26, 2022
    Classification Date
    May 12, 2022
    Address
    205 W Bement St, N/A, Bryan, OH, 43506-1264, United States

    Description

    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

    Reason

    Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

    Code Info

    UDI-DI: +B2809807QS0020CX60L. Serial Number: QS11571PLNBCX0020

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.

    Quantity

    1