Class II — Potential Health Hazard

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

RT Elements are applications for radiation treatment planning for use Recalled by Brainlab AG Due to Large objects with fine resolution are potentially displayed...

Date: November 5, 2015
Company: Brainlab AG
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 Brainlab AG directly.

Affected Products

RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

Quantity: 48 systems

Why Was This Recalled?

Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Brainlab AG

Brainlab AG has 39 total recalls tracked by RecallDetector.

Related Recalls

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