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

FDA device recall Z-2239-2025 · posted 2025-08-01 · Open, Classified

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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

Action taken

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

Root cause

Software change control

Status

Open, Classified

Product code

MUJ

Quantity affected

149 Serial Numbers

Distribution

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

Date initiated

2025-07-17

Date posted

2025-08-01

Location

Gainesville, FL

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