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 RTP System. Used to make treatment plans for patients Recalled by Elekta Inc Due to Re-optimization, after adding contours without forced density outside...

Date: February 28, 2023
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 RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Quantity: 2,020 units

Why Was This Recalled?

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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