BEUDAMED
    FDA Enforcement Class II Ongoing

    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154

    Recall: Z-1069-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1069-2024
    Event ID
    93824
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mirion Technologies (Capintec), Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2024
    Initiation Date
    November 27, 2023
    Classification Date
    February 9, 2024
    Address
    7 Vreeland Rd, N/A, Florham Park, NJ, 07932-1511, United States

    Description

    Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154

    Reason

    Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

    Code Info

    UDI: 0859942006096 and 0859942006102 Serial Numbers: 940000 through 940535

    Distribution

    Nationwide Foreign: AUSTRIA BANGLADESH BRASIL Brazil CANADA CHILE Costa Rica Ecuador France Hanoi Vietnam Hong Kong INDIA ISRAEL ITALY Malaysia PAKISTAN Philippines POLAND Saudi Arabia SOUTH KOREA Spain SWEDEN TAIWAN THAILAND TURKEY UNITED ARAB EMIATES UNITED KINGDOM VIETNAM

    Quantity

    467 units