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 ERGO++ Product Usage: ERGO is often used for stereotactic treatments. Recalled by Elekta Inc Due to Incorrect DICOM mapping of the exported collimator or...

Date: September 1, 2017
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 ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

Quantity: 182

Why Was This Recalled?

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Elekta Inc

Elekta Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report