Recall Z-2570-2025 ยท MUJ System, Planning, Radiation Therapy Treatment
Philips Medical Systems (Cleveland) Inc
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 Pinn
| Date | Sep 16, 2025 (initiated Aug 5, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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) |
| 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. |
| FDA record | Open on fda.gov |