BEUDAMED
    FDA Recall Terminated

    Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.

    Recall: Z-2312-2012 · Initiated July 24, 2012

    Recall

    Recall Number
    Z-2312-2012
    Event Number
    62982
    Firm
    Capintec Inc
    FEI Number
    2518443
    Product Code
    IZD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 24, 2012
    Posted
    September 5, 2012
    Terminated
    December 10, 2013
    Address
    620 Alpha Dr, Pittsburgh, PA, 15238

    Description

    Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.

    Reason

    Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me

    Action

    The firm, CAPINTEC, INC., sent a "SOFTWARE ERROR ALERT" letter dated July 20, 2012 to all affected consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the four measuring steps outlined in the letter; DO NOT PRINT, EXIT THE THYROID UPTAKE MODULE, OR MEASURE ANOTHER PATIENT BEFORE YOU HAVE COMPLETED THESE FOUR MEASUREMENT STEPS; and follow the attached addendum for step-by step instructions. Capintec will send corrected software to all affected customers in approximately 2-3 weeks. The customers are instructed to contact Capintec Customer Support Representative if you have any questions or concerns regarding this notification, or if you do not receive your replacement software. Capintec Customer Support can be reached by phone at 1-800-631-3826 or by email at [email protected] or by visiting our website at www.capintec.com.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.

    Quantity

    256