Class II — Potential Health Hazard

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

Helion and Xenion surgical lights Recalled by Trumpf Medical Systems, Inc. Due to Incidents regarding fractures of the front joint of...

Date: September 19, 2012
Company: Trumpf Medical Systems, 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 Trumpf Medical Systems, Inc. directly.

Affected Products

Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Quantity: 275 units

Why Was This Recalled?

Incidents regarding fractures of the front joint of the spring arm have been reported.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Trumpf Medical Systems, Inc.

Trumpf Medical Systems, Inc. has 30 total recalls tracked by RecallDetector.

Related Recalls

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