FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Recall number
- Z-2239-2025
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Status
- Open, Classified
- Initiated
- 2025-07-17
- Posted
- 2025-08-01
- Terminated
- not on file
- Reason
- Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- Root cause
- Software change control
- Action
- 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
- Quantity
- 149 Serial Numbers
- Distribution
- Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
- Lot, serial or model codes
- Software Version Number: 18.0.5/UDI: (01)00884838103566
- 510(k) numbers
- ["K170086"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3018004899
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28