Class II — Potential Health Hazard

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

Ray Station Radiation Therapy Treatment Planning System Recalled by RAYSEARCH LABORATORIES AB Due to Ray Search Laboratories found an issue with the...

Date: October 23, 2013
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

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

Quantity: 195 units domestically

Why Was This Recalled?

Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

Where Was This Sold?

US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.

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