Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

Recall date

July 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2239-2025

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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