BEUDAMED
    FDA Enforcement Class II Terminated

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    Recall: Z-0206-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0206-2013
    Event ID
    63430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland), Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    October 5, 2012
    Classification Date
    November 5, 2012
    Termination Date
    February 21, 2013
    Address
    5520 Nobel Dr Ste 125, N/A, Fitchburg, WI, 53711-4948, United States

    Description

    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

    Reason

    Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.

    Code Info

    Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347

    Distribution

    Nationwide distribution: USA including states of: ME, MI, NY, and WI.

    Quantity

    11