FDAHealthJuly 17, 2025
Philips Medical Systems (Cleveland) Inc — Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
⚠️ Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 17, 2025
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
What's affected?
- Product
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Lot code
- Software Version Number: 18.0.5/UDI: (01)00884838103566
Additional details
Software Version Number: 18.0.5/UDI: (01)00884838103566
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 149 Serial Numbers.
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