BEUDAMED
    FDA Enforcement Class II Ongoing

    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

    Recall: Z-1893-2024 · Reported June 5, 2024

    Enforcement

    Recall Number
    Z-1893-2024
    Event ID
    94570
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mirion Technologies (Capintec), Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 5, 2024
    Initiation Date
    April 22, 2024
    Classification Date
    May 24, 2024
    Address
    7 Vreeland Rd, Florham Park, NJ, 07932-1511, United States

    Description

    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.

    Reason

    Complaints of unexpected detachment of the collimator have been reported.

    Code Info

    Lot Code: Model No: 5430-30152; UDI 0859942006102; S/N range 940001 through 941398.

    Distribution

    Worldwide - US Nationwide distribution and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, FRANCE, GERMANY, GUAM, HONDURAS, HUNGARY, INDIA, ISRAEL, ISREAL, ITALY, JAPAN, KOREA, LATVIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, PHILIPPINES , PHILLIPINES, PUERTO RICO, QATAR, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TAIWAN , THAILAND, TURKEY, UNITED KINGDOM, VIETNAM.

    Quantity

    1,275 units