BEUDAMED
    FDA Recall Terminated

    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

    Recall: Z-0550-2019 · Initiated November 5, 2018

    Recall

    Recall Number
    Z-0550-2019
    Event Number
    81605
    Firm
    Capintec Inc
    FEI Number
    3000123149
    Product Code
    IZD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 5, 2018
    Posted
    December 4, 2018
    Terminated
    June 30, 2020
    Address
    7 Vreeland Road, Florham Park, NJ, 07932

    Description

    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

    Reason

    There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.

    Action

    Notification letters were sent to customers on 11/5/18. A Revised Product Alert - Corrective Action letter was sent to customers beginning 1/15/19 due to an expansion of the event.

    Distribution

    Worldwide distribution - US nationwide distributed in the states of AR, AZ, CA, CO, CT, DC, FL, IA, IN, LA, MD, MI, MN, NC, NJ, OH, OK, PA, SC, SD, TX, VA, WI, WV, and countries of Argentina, Brazil, Canada, China, Cyprus, Greece, Hong Kong, India, Japan, South Korea, Vietnam.

    Quantity

    385