BEUDAMED
    FDA Recall Terminated

    MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.

    Recall: Z-0780-2010 · Initiated December 7, 2009

    Recall

    Recall Number
    Z-0780-2010
    Event Number
    53989
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 7, 2009
    Posted
    February 19, 2010
    Terminated
    September 19, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.

    Reason

    Polymeric RF connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the RF trap assembly located below the connector and flame rating of the connector block material.

    Action

    An "Urgent-Field Safety Notice" dated December 4, 2009 was issued via certified mail to customers. The notification letter described the affected product, problem, hazard involved and action to be taken by customer. The customer will ensure to maintain frequent contact with patients during scanning and that the patient comfort kit is installed for all patient studies. The Customer will be visited by a Philips Service Representative to inspect their MRI System and install the newly remanufactured RF Connector Block. Additionally, step-by-step trap/cable installation instructions including pictures are being drafted to ensure correct installation of cabling. If you need any further information or support concerning this issue, please contact your local Philips representative or 1-800-722-9377.

    Distribution

    Worldwide distribution- United states: (AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, LA, MA, MD, ME, MN, MO, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA & WI), ARGENTINA, BRAZIL, CANADA, CHINA, CYPRUS, FRANCE, GERMANY, GREECE, ITALY, JAPAN, KOREA, NEW ZEALAND, PAKISTAN, POLAND, RUSSIA, SWITZERLAND, TAIWAN & UNITED KINGDOM.

    Quantity

    290 units