# FDA recall Z-0736-2020

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2019-11-18.

## Product

RayStation stand-alone software treatment planning system, Model Numbers 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 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

## Reason for recall

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU.  If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

## Distribution

US Nationwide distribution in the 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, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.

## Key facts

- **Recall number:** Z-0736-2020
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-01-01
- **Termination date:** 2020-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2020

## Citation

> AI Analytics. FDA recall Z-0736-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0736-2020. Source: US FDA. Licensed CC0.

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