Pinnacle Radiation Therapy Planning System recallZ-2239-2025 · Philips Medical Systems (Cleveland) Inc · initiated Jul 17, 2025
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
FDA root cause category: Software change control
What the company is doing
On July 17, 2025, Philips issued a "Urgent Medical Device Correction" Notification to affected consignees. Philips asked consignees to take the following actions: 1. You may continue to use your system(s) in accordance with the intended use and by following the recommendations below. 2. To prevent the issue from occurring, when using SPR generation, always verify data sets are from same acquisition and matching reconstruction parameters. 3. Ensure that relevant clinical staff, including physicians, physicists, and dosimetrists, are informed about the potential for incorrect dataset calculations due to mixing of data sets 4D CT spectral and SPR generation. 4. Circulate this notice to all users of this device so that they are aware of the potential issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. 5. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: [email protected]
Recall details
- Recall number
- Z-2239-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 17, 2025
- Posted by the FDA
- Aug 1, 2025
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 149 Serial Numbers
- Product code
- MUJ
- FDA submissions
- K170086
- Distribution
- Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Product description
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Code information (models, lots, serial numbers)
Software Version Number: 18.0.5/UDI: (01)00884838103566
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Pinnacle Radiation Therapy Planning System 18.0Philips Medical Systems (cleveland), Inc. · System, planning, radiation therapy treatment3 recalls4 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K170086 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Philips 459801419352Philips Medical Systems (cleveland), Inc. · System, planning, radiation therapy treatment1 recall8 reports
- Pinnacle Radiation Therapy Planning System 16.4Philips Medical Systems (cleveland), Inc. · System, planning, radiation therapy treatment1 recall3 reports
- Philips 459801050602Philips Medical Systems (cleveland), Inc. · System, planning, radiation therapy treatment1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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