# FDA recall Z-1933-2024

> **Reflexion Medical, Inc.** · Class II · device recall initiated 2024-04-16.

## Product

RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3  Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.

## Reason for recall

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

## Distribution

U.S.: CA, CT, NJ, OR, PA and TX  No O.U.S.

## Key facts

- **Recall number:** Z-1933-2024
- **Recalling firm:** Reflexion Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-16
- **Report date:** 2024-06-05

- **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-1933-2024

## Citation

> AI Analytics. FDA recall Z-1933-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1933-2024. Source: US FDA. Licensed CC0.

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