BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0550-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0550-2019
    Event ID
    81605
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Capintec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    November 5, 2018
    Classification Date
    December 4, 2018
    Termination Date
    June 30, 2020
    Address
    7 Vreeland Road, N/A, Florham Park, NJ, 07932, United States

    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.

    Code Info

    Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.

    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