Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2570-2025
• FDA 510(k) clearance · K041577The device's official FDA premarket clearance record
• FDA 510(k) clearance · K090808The device's official FDA premarket clearance record
• FDA 510(k) clearance · K170086The device's official FDA premarket clearance record
• FDA device classification · MUJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Medical Systems (Cleveland) IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.