# FDA recall Z-0470-2022

> **Reflexion Medical, Inc.** · Class II · device recall initiated 2021-11-24.

## Product

RefleXion Medical Radiotherapy System -     System Label: "*** refleXion REF RXM1000 ***"    Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"

## Reason for recall

Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

## Distribution

U.S. Nationwide distribution in the states of CA and TX

## Key facts

- **Recall number:** Z-0470-2022
- **Recalling firm:** Reflexion Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-24
- **Report date:** 2022-01-19
- **Termination date:** 2024-07-08

- **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-0470-2022

## Citation

> AI Analytics. FDA recall Z-0470-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0470-2022. Source: US FDA. Licensed CC0.

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