Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Elekta Unity Recalled by Elekta, Inc. Due to There have been reports of excessive heating in...

Date: December 18, 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

Elekta Unity, Image-Guided Radiation Therapy System

Quantity: 21 devices

Why Was This Recalled?

There have been reports of excessive heating in the MRL Gradient Connection Module.

Where Was This Sold?

This product was distributed to 3 states: IA, NY, PA

Affected (3 states)Not affected

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