BEUDAMED
    FDA Recall Terminated

    Emission Computed Tomography System

    Recall: Z-1079-04 · Initiated June 21, 2004

    Recall

    Recall Number
    Z-1079-04
    Event Number
    29480
    Firm
    Adac Labs
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2004
    Posted
    July 20, 2004
    Terminated
    December 19, 2005
    Address
    540 Alder Dr, Milpitas, CA, 95035

    Description

    Emission Computed Tomography System

    Reason

    Software problems may cause the detector head to drift unexpectedly

    Action

    Notification letter sent to consignees 6/21/2004, software update pending (mandatory upgrade)

    Distribution

    Nationwide, all direct accounts

    Quantity

    482 units