Pinnacle 3 with TumorLOC recall: Software Issue
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Why was Pinnacle 3 with TumorLOC recalled?
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version Number: 18.0.5/UDI: (01)00884838103566
- Product
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 149 Serial Numbers
- Distribution
- Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
- Recall date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)