BEUDAMED
    FDA Enforcement Class II Terminated

    Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, 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-0803-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0803-2014
    Event ID
    66591
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Civco Medical Instruments Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    October 25, 2013
    Classification Date
    January 21, 2014
    Termination Date
    February 2, 2017
    Address
    102 1st St S, Kalona, IA, 52247-9589, United States

    Description

    Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, 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.

    Code Info

    Lot#'s: M551490 and M550150

    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

    2 belly board