Class II — Potential Health Hazard

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

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning Recalled by Elekta, Inc. Due to Incorrect PEC values.

Date: June 19, 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

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

Quantity: 110 units

Why Was This Recalled?

Incorrect PEC values.

Where Was This Sold?

This product was distributed to 20 states: AK, CT, GA, KY, LA, MD, MA, MN, NM, NC, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA

Affected (20 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