BEUDAMED
    FDA Recall Terminated

    U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.

    Recall: Z-1335-2012 · Initiated April 15, 2012

    Recall

    Recall Number
    Z-1335-2012
    Event Number
    61499
    Firm
    Milabs Bv Heidelberglaan
    FEI Number
    3008406612
    Product Code
    RFK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    April 15, 2012
    Posted
    April 5, 2012
    Terminated
    August 29, 2012
    Address
    100 Str 5, 203, Utrecht Netherlands

    Description

    U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals.

    Reason

    These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally, these products do not have a certification label and the identification labels do not include the month and year of manufacture.

    Action

    A notification will be sent to all affected purchasers by April 15, 2012. The manufacturer will bring the products into compliance with the applicable performance standards within 60 days. Specifically at least one door safety interlock will be replaced per door and revised labels will be produced and applied to the system. These corrections will be made in accordance with MILabs instructions by a MILabs installation and service engineer.

    Distribution

    Nationwide Distribution -- Indiana and North Carolina.

    Quantity

    2