# FDA recall Z-0589-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2020-11-11.

## Product

RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (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)

## Reason for recall

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0589-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2020-12-23
- **Termination date:** 2023-05-09

- **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-0589-2021

## Citation

> AI Analytics. FDA recall Z-0589-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0589-2021. Source: US FDA. Licensed CC0.

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