Class II — Potential Health Hazard

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

DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Recalled by Elekta, Inc. Due to Clinical mistreatment may occur when there are errors...

Date: August 15, 2013
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

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

Quantity: 31

Why Was This Recalled?

Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

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