BEUDAMED
    FDA Recall Terminated

    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

    Recall: Z-0988-2012 · Initiated November 18, 2011

    Recall

    Recall Number
    Z-0988-2012
    Event Number
    60902
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 18, 2011
    Posted
    February 10, 2012
    Terminated
    February 22, 2013
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.

    Reason

    Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.

    Action

    On 11/15/2011 Philips sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected product, the problem, the hazard involved, and the actions to be taken by users and the Philips. Customers are to place the letter in their User Documentation. Philips service will arrange a time to inspect customers' systems and conduct the appropriate field safety correction. Customers are to contact their local Philips representative if they need further support or information. In the US and Canada, customers can contact Philips Healthcare Customer Care Solutions Center at 1-800-722-9377.

    Distribution

    Worldwide Distribution -- USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PRO, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and the territory of Puerto Rico; and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Egypt, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, & United Kingdom.

    Quantity

    795 units