# FDA recall Z-1656-2026

> **Reflexion Medical, Inc.** · Class II · device recall initiated 2026-02-09.

## Product

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

## Reason for recall

Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.

## Distribution

US: CA, TX, PA, CT, NJ, OR, LA, OH

## Key facts

- **Recall number:** Z-1656-2026
- **Recalling firm:** Reflexion Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-09
- **Report date:** 2026-04-08

- **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-1656-2026

## Citation

> AI Analytics. FDA recall Z-1656-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1656-2026. Source: US FDA. Licensed CC0.

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