BEUDAMED
    FDA Recall Terminated

    Trolley for Intera/NT MRI System

    Recall: Z-1028-04 · Initiated May 13, 2004

    Recall

    Recall Number
    Z-1028-04
    Event Number
    29229
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2004
    Posted
    July 20, 2004
    Terminated
    April 8, 2005
    Address
    22100 Bothell Everett Highway, Bothell, WA, 98041

    Description

    Trolley for Intera/NT MRI System

    Reason

    Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.

    Action

    The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley.

    Distribution

    Product was distributed to hospitals and medical centers nationwide.

    Quantity

    57 devices