Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RayStation Radiation Therapy Treatment Planning System Recalled by RAYSEARCH LABORATORIES AB Due to Potential for dose errors due to software program...

Date: February 6, 2014
Company: RAYSEARCH LABORATORIES AB
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact RAYSEARCH LABORATORIES AB directly.

Affected Products

RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

Quantity: 151 units Total (88 units domestically & 63 units internationally)

Why Was This Recalled?

Potential for dose errors due to software program errors.

Where Was This Sold?

This product was distributed to 15 states: AZ, CA, CO, CT, DE, FL, IL, MD, MS, NJ, NY, OH, PA, TN, WA

Affected (15 states)Not affected

About RAYSEARCH LABORATORIES AB

RAYSEARCH LABORATORIES AB has 113 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report