# FDA recall Z-1838-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-04-21.

## Product

RayStation (Treatment Planning System)  Model Number	RayStation is  6.0.0.24 ,  6.1.1.2 ,  6.2.0.7 ,  6.3.0.6 ,  7.0.0.19 ,  8.0.0.6 ,  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  or  10.1.0.613 .

## Reason for recall

Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Hong Kong, China, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK,

## Key facts

- **Recall number:** Z-1838-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-21
- **Report date:** 2021-06-16
- **Termination date:** 2023-07-27

- **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-1838-2021

## Citation

> AI Analytics. FDA recall Z-1838-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1838-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*