# FDA recall Z-2486-2025

> **Reflexion Medical, Inc.** · Class II · device recall initiated 2025-07-22.

## Product

RefleXion X1 Model RXM1000  UDI Codes:  (01)00860003983812(11)230504(21)X11001  (01)00860003983812(11)230518(21)X11002  (01)00860003983812(11)230505(21)X11003  (01)00860003983812(11)230530(21)X11004  (01)00860003983812(11)230811(21)X11006  (01)00860003983812(11)230410(21)X11007  (01)00860003983812(11)230803(21)X11008  (01)00860003983812(11)240528(21)X11009  (01)00860003983812(11)240820(21)X11010  (01)00860003983812(11)241107(21)X11011  (01)00860003983812(11)241206(21)X11012    The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator.  The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography  detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.

## Reason for recall

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

## Distribution

U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.

## Key facts

- **Recall number:** Z-2486-2025
- **Recalling firm:** Reflexion Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-22
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hayward, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2025

## Citation

> AI Analytics. FDA recall Z-2486-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2486-2025. Source: US FDA. Licensed CC0.

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