BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 26, 2022

    Recall

    Recall Number
    Z-1074-2022
    Event Number
    89990
    Firm
    Daavlin Distributing Company
    FEI Number
    1526255
    Product Code
    FTC
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    April 26, 2022
    Address
    205 W Bement St, Bryan, OH, 43506-1264

    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.

    Action

    Beginning April 26, 2022 Daavlin Distributing Co. is sent a recall notification letter via certified mail to customers. Customers are to acknowledge receipt of the notification and a company representative will call customers to arrange for return of the devices to update software. If you have any questions or concerns, contact the company at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, EST.

    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