Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
FDA Recall #Z-2239-2025 — Class II — July 17, 2025
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) ,
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
149 Serial Numbers
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated