BEUDAMED
    FDA Enforcement Class II Ongoing

    Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

    Recall: Z-2570-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2570-2025
    Event ID
    97049
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2025
    Initiation Date
    August 5, 2025
    Classification Date
    September 16, 2025
    Address
    3630 Sw 47th Ave, N/A, Gainesville, FL, 32608-7555, United States

    Description

    Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

    Reason

    Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

    Code Info

    Pinnacle¿ Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model Number: 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Lot Number (Software Version): 18.0.5 Pinnacle TumorLOC 16.2 Model Number: 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Lot Number (Software Version): 16.2 Pinnacle TumorLOC 16.2.1 Model Number: 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Lot Number (Software Version): 16.2.1 Pinnacle TumorLOC 16.0.2 Model Number: 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Lot Number (Software Version): 16.0.2 Pinnacle TumorLOC 14.0 Model Number: 870200 UDI code: N/A Lot Number (Software Version): 14.0

    Distribution

    U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

    Quantity

    810 (350 U.S. and 460 O.U.S.)