BEUDAMED
    FDA Enforcement Class II Ongoing

    Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

    Recall: Z-2239-2025 · Reported August 13, 2025

    Enforcement

    Recall Number
    Z-2239-2025
    Event ID
    97309
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2025
    Initiation Date
    July 17, 2025
    Classification Date
    August 1, 2025
    Address
    3630 Sw 47th Ave, N/A, Gainesville, FL, 32608-7555, United States

    Description

    Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

    Reason

    Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

    Code Info

    Software Version Number: 18.0.5/UDI: (01)00884838103566

    Distribution

    Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.

    Quantity

    149 Serial Numbers