—#215163

Product

Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K170086
Affected lot / code info: Software Version Number: 18.0.5/UDI: (01)00884838103566

Why it was recalled

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

Root cause (FDA determination)

Software change control

Action the firm took

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: Philips.recall@philips.com

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 3630 Sw 47th Ave, Gainesville, Florida 32608-7555

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.

Timeline

Recall initiated: 2025-07-17
Posted by FDA: 2025-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.