BEUDAMED
    FDA Recall Terminated

    Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143

    Recall: Z-1511-2008 · Initiated November 21, 2007

    Recall

    Recall Number
    Z-1511-2008
    Event Number
    45894
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 21, 2007
    Posted
    September 19, 2008
    Terminated
    February 25, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143

    Reason

    Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.

    Action

    Consignees were sent an Urgent Field Safety Notice on 1/30/08. The letter instructs users who experience a failure to remove the system from service and contact the recalling firm for immediate correction. The recalling firm will schedule appointments with users to replace the affected part beginning in March 2008. For additional information, contact 1-800-722-9377.

    Distribution

    Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.

    Quantity

    Unknown at this time sinc the recall was expanded.