Pinnacle 3 with TumorLOC — Class II medical device recall Z-2239-2025
Ongoing recall by Philips Medical Systems (Cleveland) Inc, reported 2025-08-13, distributed nationwide. Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when perfo
| Recall number | Z-2239-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Gainesville, FL, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-08-01 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 149 serial |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838103566 |
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Reason for recall
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2239-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.