FDA-Device2025-08-13Class II
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland) Inc
Hazard
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Sold states
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Affected count
149 Serial Numbers
Manufactured in
3630 Sw 47th Ave, N/A, Gainesville, FL, United States
Products
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2025Don't want to check this manually?
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