CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled
Philips Medical Systems (Cleveland) is recalling Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System, distributed nationwide in the US. The recall was initiated on 17 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2239-2025
- FDA event ID
- 97309
- Recalling firm
- Philips Medical Systems (Cleveland), Gainesville, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2025
- FDA classified
- 1 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 17 Jul 2025 | Recall initiated by company | |
| 1 Aug 2025 | Classified by FDA | +15 days |
| 13 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Where it was distributed
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
Questions about this recall
Why was it recalled?
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Which lots are affected?
Software Version Number: 18.0.5/UDI: (01)00884838103566
Where was it sold?
Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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