BEUDAMED
    FDA Recall Terminated

    Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

    Recall: Z-0369-05 · Initiated December 1, 2004

    Recall

    Recall Number
    Z-0369-05
    Event Number
    30569
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 1, 2004
    Posted
    December 24, 2004
    Terminated
    February 10, 2006
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021

    Description

    Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811

    Reason

    X-Ray system may fall downward and could possibly hit the patient.

    Action

    A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.

    Distribution

    The firm distributed this product to hospitals and medical centers nationwide.

    Quantity

    44 total units (Thoravision I and II)