BEUDAMED
    FDA Recall Terminated

    Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

    Recall: Z-0802-2014 · Initiated October 25, 2013

    Recall

    Recall Number
    Z-0802-2014
    Event Number
    66591
    Firm
    Civco Medical Instruments Inc
    FEI Number
    1937223
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2013
    Posted
    January 21, 2014
    Terminated
    February 2, 2017
    Address
    102 1st St S, Kalona, IA, 52247-9589

    Description

    Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

    Reason

    Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

    Action

    Civco Medical Instruments Inc sent a FIELD SAFETY NOTIFICATION letter dated October 28, 2013 via UPS to their customers. The notification identified the affected device, problem, and field safety corrective action. The letter describes how customers can check to see whether the scales on their device are out of alignment. The letter states CIVCO will rework the system to correct the difference. For questions contact sales representative at CIVCO Medical Solutions, Radiation Oncology at 800-842-8688 or 712-737-8688.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

    Quantity

    138 belly boards