Pinnacle Radiation Therapy Planning System recall: Software Issue
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236…
Why was Pinnacle Radiation Therapy Planning System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 810 (350 U.S. and 460 O.U.S.)
- Distribution
- U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Recall date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)