BEUDAMED
    FDA Recall Terminated

    PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

    Recall: Z-1218-2007 · Initiated August 10, 2007

    Recall

    Recall Number
    Z-1218-2007
    Event Number
    38512
    Firm
    Summit Industries Inc.
    FEI Number
    1450503
    Product Code
    IZX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2007
    Posted
    August 29, 2007
    Terminated
    March 18, 2010
    Address
    2901 W Lawrence Ave, Chicago, IL, 60625-3621

    Description

    PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries, Inc., Chicago, Illinois

    Reason

    The F100 Swivel Collimator may come loose from the tubestand and fall onto the x-ray table.

    Action

    The affected dealers were notified of the field correction recall by letter dated 8/3/07, informing them of the problem with the stripped screws and requesting that they notify their affected end user locations. The end user notification letters inform them of the problem and state that the dealer will be contacting them soon to arrange a time to visit the end user location and conduct the rework on the collimator, which should take less than 30 minutes. In the mean time the end user was instructed to examine their swivel collimator for looseness. If it is found to be loose, the end user was instructed to take the unit out of service and call the dealer.

    Distribution

    Worldwide, including USA, Australia, Cambodia, Canada, Chile, Colombia, Dominican Republic, Ecuador, France, Germany, Haiti, Mexico, Nicaragua, Singapore, and South Africa.

    Quantity

    3034 for all units