Reported Sep 24, 2025 · Ongoing
Pinnacle Radiation Therapy Planning System
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¿ Radiation Therapy Planning System
10 of 10 products
| Model / number | Barcodes | Product as published |
|---|---|---|
870258 | 00884838103566 | UDI code: (01)00884838103566(10)18.0.5.22236 |
| — | Lot Number (Software Version): 18.0.5 Pinnacle TumorLOC 16.2 | |
870226 | 00884838091122 | UDI code: (01)00884838091122(10)16.2.0.60010 |
| — | Lot Number (Software Version): 16.2 Pinnacle TumorLOC 16.2.1 | |
870227 | 00884838091122 | UDI code: (01)00884838091122(10)16.2.1.60098 |
| — | Lot Number (Software Version): 16.2.1 Pinnacle TumorLOC 16.0.2 | |
870218 | 00884838085602 | UDI code: (01)00884838085602(10)16.0.2.60004 |
| — | Lot Number (Software Version): 16.0.2 Pinnacle TumorLOC 14.0 | |
870200 | UDI code: N/A | |
| — | Lot Number (Software Version): 14.0 |
- Amount recalled
- 810 (350 U.S. and 460 O.U.S.)
Where it was sold
Why it was recalled
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
This product could cause temporary or reversible health problems — stop using it.
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