# FDA recall Z-2239-2025

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2025-07-17.

## 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) ,

## Distribution

Worldwide - US Nationwide distribution in the state of WV and the countries of Macao  & United Kingdom.

## Key facts

- **Recall number:** Z-2239-2025
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-17
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2025

## Citation

> AI Analytics. FDA recall Z-2239-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2239-2025. Source: US FDA. Licensed CC0.

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