BEUDAMED
    FDA Recall Terminated

    Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.

    Recall: Z-0167-2011 · Initiated September 20, 2010

    Recall

    Recall Number
    Z-0167-2011
    Event Number
    56975
    Firm
    Capintec Inc
    FEI Number
    2518443
    Product Code
    KPT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 20, 2010
    Posted
    October 28, 2010
    Terminated
    July 5, 2012
    Address
    620 Alpha Dr, Pittsburgh, PA, 15238

    Description

    Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.

    Reason

    The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.

    Action

    Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.

    Distribution

    Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.

    Quantity

    9 units