# FDA recall Z-0478-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2020-10-08.

## Product

RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

## Reason for recall

If a region of interest (ROI)  or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure  Set, the reference may become linked to the wrong ROI or POI.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0478-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-12-02
- **Termination date:** 2023-03-30

- **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-0478-2021

## Citation

> AI Analytics. FDA recall Z-0478-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0478-2021. Source: US FDA. Licensed CC0.

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