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 Image-Guided Radiation Therapy System containing an MR gradient Recalled by Elekta, Inc. Due to There is a low possibility that an electrical...

Date: April 6, 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

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Quantity: 18 devices

Why Was This Recalled?

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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