# FDA recall Z-2570-2025

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2025-08-05.

## Product

Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

## Reason for recall

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

## Distribution

U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

## Key facts

- **Recall number:** Z-2570-2025
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-09-24

- **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-2570-2025

## Citation

> AI Analytics. FDA recall Z-2570-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2570-2025. Source: US FDA. Licensed CC0.

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