Class II — Potential Health Hazard

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

XiO Radiation Treatment Planning System. Used to create treatment plans Recalled by Elekta, Inc. Due to Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Date: August 31, 2015
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

XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

Quantity: 1440 units

Why Was This Recalled?

Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Where Was This Sold?

This product was distributed to 28 states: AL, AK, AZ, CA, CO, CT, FL, IL, IN, KY, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, PA, TN, TX, VA, WA, WI, DC

Affected (28 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