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 Therapy Treatment Planning System Stand-alone Software 3.0 Recalled by RAYSEARCH LABORATORIES AB Due to A software issue with editing tools that use...

Date: February 10, 2016
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 Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.

Quantity: 1,264 Total units (552 units domestically & 711 units internationally)

Why Was This Recalled?

A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.

Where Was This Sold?

This product was distributed to 24 states: AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MA, MI, MS, NV, NJ, NY, NC, OH, OR, PA, RI, TN, WA

Affected (24 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