# FDA recall Z-1281-2023

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2023-02-17.

## Product

Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0.  Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs

## Reason for recall

It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1281-2023
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-17
- **Report date:** 2023-03-29

- **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-1281-2023

## Citation

> AI Analytics. FDA recall Z-1281-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1281-2023. Source: US FDA. Licensed CC0.

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