Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 8/1/2025
Class: II

PRODUCT

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

Recall Number:

Z-2239-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

Philips Medical Systems (Cleveland) Inc

VOLUME:

149 Serial Numbers

DISTRIBUTION:

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