BEUDAMED
    FDA Recall Terminated

    POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.

    Recall: Z-0196-05 · Initiated September 23, 2004

    Recall

    Recall Number
    Z-0196-05
    Event Number
    30170
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 23, 2004
    Posted
    November 16, 2004
    Terminated
    January 25, 2005
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.

    Reason

    Orbital gears may exhibit excess wear

    Action

    The recalling firm issued Update Instructions, AX077/04/S, to Siemen''s Customer Service Representative (CSR) to visit affected sites and check the orbital gears for excessive wear. If the CSR finds gears exhibiting excessive wear the orbital gears will be replaced. If no wear is observed the gears will be lubricated as a preventive measure.

    Distribution

    The product was shipped to medical facilities nationwide and government accounts in KS and MI.

    Quantity

    82 units