Z-2570-2025Class II

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code...

Name: Z-2570-2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2025-08-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-08-05 / Open, Classified / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle... on 2025-08-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2570-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-09-16
Recalling firm: Philips North America LLC
Product: 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 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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 tag: software
FDA 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) 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: [email protected]. 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2570-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2570-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-16

Product code MUJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)