# FDA recall Z-0866-2020

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2019-12-19.

## Product

RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.

## Reason for recall

Three issues found: i) 	The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.

## Distribution

US Nationwide distribution in states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, WI

## Key facts

- **Recall number:** Z-0866-2020
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-19
- **Report date:** 2020-02-05
- **Termination date:** 2020-11-24

- **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-0866-2020

## Citation

> AI Analytics. FDA recall Z-0866-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0866-2020. Source: US FDA. Licensed CC0.

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