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 (RTP) System Recalled by Elekta Inc Due to Monaco is using the incorrect energy when optimizing...

Date: November 22, 2019
Company: Elekta Inc
Status: Ongoing
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 (RTP) System

Quantity: 76 (7 US, 69 OUS)

Why Was This Recalled?

Monaco is using the incorrect energy when optimizing and calculating dose.

Where Was This Sold?

This product was distributed to 6 states: IN, IA, NY, OH, TX, WI

Affected (6 states)Not affected

About Elekta Inc

Elekta Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

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