BEUDAMED
    FDA Recall Terminated

    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

    Recall: Z-1312-2014 · Initiated February 11, 2014

    Recall

    Recall Number
    Z-1312-2014
    Event Number
    67623
    Firm
    Philips Medical Systems (Cleveland), Inc.
    FEI Number
    3004022368
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 11, 2014
    Posted
    March 31, 2014
    Terminated
    November 21, 2014
    Address
    5520 Nobel Dr, Ste 125, Fitchburg, WI, 53711-4948

    Description

    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.

    Reason

    Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from 09/29/09 to 12/01/2013.

    Action

    Philips Healthcare sent an Urgent Field Safety Notice dated February 10, 2014, to all affected consignees. The letter included the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be taken by Customer /User, Actions Planned by Philips and Further Information and Support. Consignees were instructed to review the following information with all members of their staff who need to be aware of the contents of this communication including clinics within their institution that are remotely connected to their Pinnacle Server. Customers were questions were instructed to contact their Philips representative. For customers in North America please contact Customer Care Solutions Center at 1-800-722-9377. For all other countries their local Philips Healthcare Office should be contacted. For questions regarding this recall call 1-800-722-9377.

    Distribution

    Worldwide Distribution - USA including US: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Internationally to AUSTRALIA, AUSTRIA. BELGIUM, CANDA, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, RUSSIA, SOUTH ARICA, SOUTH KOREA. SPAIN,. SWITZERLAND, TAIWAN, THAILAND, TURKEY, EMIRATES, UNITED KINGDOM. .

    Quantity

    1016