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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle 3 with TumorLOC Software

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 Class 2 Device Recall Pinnacle 3 with TumorLOC Softwaresee related information
Date Initiated by FirmJuly 17, 2025
Date PostedAugust 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2239-2025
Recall Event ID 97309
510(K)NumberK170086 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductPinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Code Information Software Version Number: 18.0.5/UDI: (01)00884838103566
FEI Number 3018004899
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
3630 Sw 47th Ave
Gainesville FL 32608-7555
For Additional Information ContactPhilips Customer Care Center
1800-722-9377
Manufacturer Reason
for Recall		Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
FDA Determined
Cause 2		Software change control
ActionOn 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
Quantity in Commerce149 Serial Numbers
DistributionWorldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUJ
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