FDA-Device2025-08-13Class II
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
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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