BEUDAMED
    FDA Recall Terminated

    Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01

    Recall: Z-0840-05 · Initiated April 7, 2005

    Recall

    Recall Number
    Z-0840-05
    Event Number
    31457
    Firm
    Dunlee
    FEI Number
    1483239
    Product Code
    ITY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2005
    Posted
    May 13, 2005
    Terminated
    October 20, 2005
    Address
    555 Commerce St, Aurora, IL, 60504-8110

    Description

    Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Dunlee, 555 North Commerce Street, Aurora, Illinois 60504 U.S.A.; part number 875-01

    Reason

    The x-ray tube housing assembly may have been mounted with the incorrect sized bolts.

    Action

    Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.

    Distribution

    Nationwide and internationally to Taiwan, Germany and Mexico.

    Quantity

    37 units