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.
