FDA Device recall Z-2239-2025
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software by Philips Medical Systems Cleveland, citing due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2239-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-17 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Reason
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Identifiers
| code_info | Software Version Number: 18.0.5/UDI: (01)00884838103566 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Philips Medical Systems Cleveland
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.2…
FDA Device · Class II · 2025-09-24 · Philips Medical Systems Cleveland - Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237
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All Philips Medical Systems Cleveland recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2025%22
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