Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 24, 2025
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236
🔢 810 (350 U.S. and 460 O.U.S.)
Sold At: Philips Medical Systems (Cleveland) Inc(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 #: FDA-DEVICE-Z-2570-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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
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Summary
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 to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Philips Medical Systems (Cleveland) Inc for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.