BEUDAMED
    FDA Enforcement Class II 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 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2312-2012
    Event ID
    62982
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Capintec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2012
    Initiation Date
    July 24, 2012
    Classification Date
    September 5, 2012
    Termination Date
    December 10, 2013
    Address
    620 Alpha Dr, N/A, Pittsburgh, PA, 15238, United States

    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

    Code Info

    Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)

    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