Z-2239-2025Class II

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

Name: Z-2239-2025 Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2025-07-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-07-17 / Open, Classified / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software on 2025-07-17. FDA classified it as Class II and gives the reason as "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2239-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-17
Posted: 2025-08-01
Recalling firm: Philips North America LLC
Product: Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Root cause tag: software
FDA 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: [email protected]
Quantity in commerce: 149 Serial Numbers
Distribution: Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Product codes and lots: Software Version Number: 18.0.5/UDI: (01)00884838103566

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2239-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2239-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01

Product code MUJ

K170086Class IIPinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2017-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)