# FDA recall Z-0380-2018

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2017-07-17.

## Product

RayStation     Product Usage:  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.

## Reason for recall

For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.

## Distribution

US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.

## Key facts

- **Recall number:** Z-0380-2018
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-17
- **Report date:** 2018-01-24
- **Termination date:** 2018-08-29

- **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-0380-2018

## Citation

> AI Analytics. FDA recall Z-0380-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0380-2018. Source: US FDA. Licensed CC0.

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