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 displaying the Anatomy and Beam shift...

Date: August 23, 2019
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 (RTP) System

Quantity: 49 units

Why Was This Recalled?

Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.

Where Was This Sold?

Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.

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