# FDA recall Z-0849-2022

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-09-22.

## Product

RayStation/RayPlan versions 4 - 11A, including service packs.  Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29

## Reason for recall

An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-0849-2022
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-22
- **Report date:** 2022-04-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0849-2022

## Citation

> AI Analytics. FDA recall Z-0849-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0849-2022. Source: US FDA. Licensed CC0.

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