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Pinnacle Radiation Therapy Planning System recallZ-2570-2025 · Philips Medical Systems (Cleveland) Inc · initiated Aug 5, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems (Cleveland) Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-2570-2025
Status
Open, Classified
Initiated by the company
Aug 5, 2025
Posted by the FDA
Sep 16, 2025
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
810 (350 U.S. and 460 O.U.S.)
Product code
MUJ
FDA submissions
K041577, K090808, K170086
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 description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K041577, K090808, K170086 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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