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 Medical Linear Accelerator (ELMA) included in the below platforms: Recalled by Elekta, Inc. Due to A component within a limited number of Elekta...

Date: May 5, 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 Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

Quantity: 46 units

Why Was This Recalled?

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

Where Was This Sold?

This product was distributed to 7 states: AR, IN, LA, OK, TN, VA, WA

Affected (7 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