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 When creating 3D plans using either MU or...

Date: July 3, 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 RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Quantity: 1396 units

Why Was This Recalled?

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

Where Was This Sold?

worldwide

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