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 Recalled by Elekta Inc Due to If a couch is removed while a plan...

Date: July 26, 2021
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, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Quantity: N/A

Why Was This Recalled?

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

Where Was This Sold?

This product was distributed to 7 states: IA, NJ, NY, PA, TN, TX, WI

Affected (7 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