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 Product Usage: Intended for use with rotating gantry Recalled by Elekta, Inc. Due to It is possible for an intermittent error to...

Date: May 1, 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 Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.

Quantity: 35 units

Why Was This Recalled?

It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV 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