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Philips Medical Systems (Cleveland) Inc
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips Medical Systems (Cleveland) Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-24FDA-DeviceClass IIPinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning
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.
- 2025-08-13FDA-DeviceClass IIPinnacle 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) ,
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