FDA recall Z-2239-2025

Philips Medical Systems (Cleveland) Inc · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-07-17
Report date: 2025-08-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2025