Reported Aug 13, 2025 · Ongoing
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 3630 Sw 47th Ave · Gainesville, FL · 32608-7555
Is this the product you have?
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Lot codes and dates
- Software Version Number18.0.5/UDI: (01)00884838103566
- Amount recalled
- 149 Serial Numbers
Where it was sold
- Nationwide
- WV
Why it was recalled
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
This product could cause temporary or reversible health problems — stop using it.
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