# FDA recall Z-1299-2022

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2022-06-10.

## Product

RayStation 11B

## Reason for recall

This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation   11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display  might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync   with the selected beam.

## Distribution

US Nationwide distribution in the states of NJ and TX.

## Key facts

- **Recall number:** Z-1299-2022
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-10
- **Report date:** 2022-07-06
- **Termination date:** 2024-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2022

## Citation

> MORVS. FDA recall Z-1299-2022. Retrieved 2026-11-02 from https://api.morvs.ai/recall/Z-1299-2022. Source: US FDA. Licensed CC0.

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