Class II — Potential Health Hazard

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

Monaco Radiation Treatment Planning System. Used to make treatment plans Recalled by Elekta, Inc. Due to Dose and MU are incorrect when CT images...

Date: September 15, 2015
Company: Elekta, Inc.
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 Elekta, Inc. directly.

Affected Products

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Quantity: 154 units

Why Was This Recalled?

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

Where Was This Sold?

This product was distributed to 6 states: CA, IN, MI, MO, TX, WI

Affected (6 states)Not affected

About Elekta, Inc.

Elekta, Inc. has 100 total recalls tracked by RecallDetector.

Related Recalls

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