Pinnacle Radiation Therapy System (Philips) – image error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pinnacle 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 System is a soft
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Pinnacle¿ Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model Number: 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Lot Number (Software Version): 18.0.5 Pinnacle TumorLOC 16.2 Model Number: 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Lot Number (Software Version): 16.2 Pinnacle TumorLOC 16.2.1 Model Number: 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Lot Number (Software Version): 16.2.1 Pinnacle TumorLOC 16.0.2 Model Number: 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Lot Number (Software Version): 16.0.2 Pinnacle TumorLOC 14.0 Model Number: 870200 UDI code: N/A Lot Number (Software Version): 14.0
Philips Medical Systems (Cleveland) Inc is recalling Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 due to 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 Fi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 08/05/2025, the firm sent via FedEx an "Urgent Medical Device Correction" Letter informing customers of a software issue affecting the Pinnacle3 Radiation Therapy Planning System performing Advanced Region of Interest (ROI) Expansion and Contraction that results in a potential shift of the intended ROI. The software assumes the patient is always in the Head First Supine (HFS) position when transposing the Advanced Expansion to alternate positions. Customers are instructed to: -When using the Advanced ROI Expansion and Contraction feature in Pinnacle3, only use the Head First Supine (HFS) patient orientation. -Ensure that relevant clinical staff, including physicians, physicists, and dosimetrists, are informed about the potential for directional errors in ROI expansion/contraction under certain orientation conditions. -Customers may continue to use your system(s) in accordance with the intended use and by following the recommendations above. -Circulate this notice to all users of this device so that they are aware of the potential issue. -Retain this letter with their system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. -Complete and return the updated attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: Philips.recall@philips.com. Note: If customers have returned a response form already in reply to the initial customer letter, complete and sign this updated response form and return to Philips. Philips will provide a label to be affixed to the device that provides instruction to use the HFS position only. A Philips representative will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site to attach /affix the label to the workstation (Reference 2025-EI-TPS-002). Questions-contact your local Philips representative: For North America, contact Philips Customer Care Center at 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026