Device product

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

Z-2239-2025

July 17, 2025

Class II

Product summary

Firm: Philips Medical Systems (Cleveland) Inc
Event: Event 97309
Status: Ongoing
Classification: Class II
Quantity: 149 Serial Numbers
Official record key: device-enforcement:Z-2239-2025

Official wording

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

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

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

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software issue, Radiation Therapy Planning system may provide incorrect