Class II

Medical Device Recall: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

Philips Medical Systems (Cleveland) Inc · July 17, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

149 Serial Numbers

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2239-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips Medical Systems (Cleveland) Inc Medical Device Recall: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software | SafeCheck