BEUDAMED
    FDA Recall Terminated

    AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.

    Recall: Z-1642-2008 · Initiated March 14, 2008

    Recall

    Recall Number
    Z-1642-2008
    Event Number
    47487
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    IXI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 14, 2008
    Posted
    September 1, 2008
    Terminated
    July 18, 2012
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.

    Reason

    Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.

    Action

    On 03/22/2004, firm sent letters via certified mail to notify customers of issue. Letter advises customers of potential risk for patients and users, and states to not use system for critical examinations or treatments if table movements suddenly stops or makes a freeing movement. The letter indicates a representative will contact customer for installation of a Hardware filter, free of charge, to prevent Electromagnetic interference (EMI) from affecting the force sensor. Please contact Philips at 1-800-722-9377 #5, #4, #1.

    Distribution

    Product is distributed to hospitals and medical centers nationwide to the following states: ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL.

    Quantity

    39 units