Class II — Potential Health Hazard

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

Integrity 1.1. Integrity is the interface and control software for Recalled by Elekta, Inc. Due to The problem is that the "static tolerances" from...

Date: March 28, 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

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Quantity: 498

Why Was This Recalled?

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

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