Class II — Potential Health Hazard

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

Radiation Therapy Treatment Planning System Recalled by RAYSEARCH LABORATORIES AB Due to For a treatment plan consisting of multiple beam...

Date: May 30, 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

Radiation Therapy Treatment Planning System, Model 5.0

Quantity: 491 units (187 domestically & 304 internationally)

Why Was This Recalled?

For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.

Where Was This Sold?

This product was distributed to 9 states: AZ, CA, FL, MT, NY, NC, OH, TX, WA

Affected (9 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