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 used to make treatment plans Recalled by Elekta, Inc. Due to Unintended update of Dose and MU and Incorrect...

Date: October 16, 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 used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Quantity: 154

Why Was This Recalled?

Unintended update of Dose and MU and Incorrect Assignment of Bolus.

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