Pinnacle 3 TumorLOC (Philips) – Calculation Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Software Version Number: 18.0.5/UDI: (01)00884838103566
Products Sold
Software Version Number: 18.0.5/UDI: (01)00884838103566
Philips Medical Systems (Cleveland) Inc is recalling Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software due to Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026