{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214359", "product_res_number": "Z-2570-2025", "event_date_initiated": "2025-08-05", "event_date_posted": "2025-09-16", "recall_status": "Open, Classified", "res_event_number": "97049", "product_code": "MUJ", "k_numbers": [ "K041577", "K090808", "K170086" ], "product_description": "Pinnacle Radiation Therapy Planning System:\n\nMultimodality Simulation Workspace 18.0.5 Model 870258\nUDI code: (01)00884838103566(10)18.0.5.22236\n\nPinnacle TumorLOC 16.2 Model 870226\nUDI code: (01)00884838091122(10)16.2.0.60010\n\nPinnacle TumorLOC 16.2.1 Model 870227\nUDI code: (01)00884838091122(10)16.2.1.60098\n\nPinnacle TumorLOC 16.0.2 Model 870218\nUDI code: (01)00884838085602(10)16.0.2.60004\n\nPinnacle TumorLOC 14.0 Model 870200\nUDI code: N/A\n\nPinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.", "code_info": "Pinnacle¿ Radiation Therapy Planning System:\n\nMultimodality Simulation Workspace 18.0.5\nModel Number: 870258\nUDI code: (01)00884838103566(10)18.0.5.22236\nLot Number (Software Version): 18.0.5\n\nPinnacle TumorLOC 16.2\nModel Number: 870226\nUDI code: (01)00884838091122(10)16.2.0.60010\nLot Number (Software Version): 16.2\n\nPinnacle TumorLOC 16.2.1\nModel Number: 870227\nUDI code: (01)00884838091122(10)16.2.1.60098\nLot Number (Software Version): 16.2.1\n\nPinnacle TumorLOC 16.0.2\nModel Number: 870218\nUDI code: (01)00884838085602(10)16.0.2.60004\nLot Number (Software Version): 16.0.2\n\nPinnacle TumorLOC 14.0\nModel Number: 870200\nUDI code: N/A\nLot Number (Software Version): 14.0", "firm_fei_number": "3018004899", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "3630 Sw 47th Ave", "city": "Gainesville", "state": "FL", "postal_code": "32608-7555", "additional_info_contact": "Philips Customer Care Center\n800-722-9377", "reason_for_recall": "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_description": "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.\n\nCustomers are instructed to:\n-When using the Advanced ROI Expansion and Contraction feature in Pinnacle3, only use the Head First Supine (HFS) patient orientation.\n-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.\n-Customers may continue to use your system(s) in accordance with the intended use and by following the recommendations above.\n-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.\n-Complete and return the updated attached response form to Philips promptly and no\nlater than 30 days from receipt of this letter via email to: Philips.recall@philips.com.\nNote: 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.\n\nPhilips will provide a label to be affixed to the device that provides instruction to use the HFS position only.\nA 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).\nQuestions-contact your local Philips representative: For North America, contact Philips Customer Care Center at 1-800-722-9377.", "product_quantity": "810 (350 U.S. and 460 O.U.S.)", "distribution_pattern": "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 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