Drug recall
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
FDA recall event 97309 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 97309 |
|---|---|
| Recall numbers | Z-2239-2025 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) , |
| Initiation date | Jul 17, 2025 |
| Report date | Aug 13, 2025 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 3018004899 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: