Home / Recalls / Philips Medical Systems (Cleveland) Inc / Z-2239-2025

Z-2239-2025 Class II Ongoing

Recalled by Philips Medical Systems (Cleveland) Inc — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
August 13, 2025
Initiation Date
July 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
149 Serial Numbers

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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

Other recalls by Philips Medical Systems (Cleveland) Inc

  • Z-2570-2025 Class II — Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspac (August 5, 2025)
  • Z-1744-2022 Class II — Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. (August 30, 2022)
  • Z-0214-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0213-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0217-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0215-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0216-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-2192-2019 Class II — IQon Spectral CT Model # 728332, computed tomography x-ray system (June 24, 2019)
  • Z-2190-2019 Class II — iCT SP Model # 728311, computed tomography x-ray system (June 24, 2019)
  • Z-2189-2019 Class II — iCT, Model # 728306, computed tomography x-ray system (June 24, 2019)