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

Recalled August 13, 2025 · FDA recall Z-2239-2025 · Philips Medical Systems (Cleveland)

Hazard

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

Units

149 Serial Numbers

Sold at

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

Description

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

Product

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

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →