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 S Exam Light or H300 The device is intended Recalled by Trumpf Medical Systems, Inc. Due to Possible fatigue failure of the plastic joint may...

Date: February 19, 2013
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 S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.

Quantity: 287

Why Was This Recalled?

Possible fatigue failure of the plastic joint may occur after an average use of seven years.

Where Was This Sold?

This product was distributed to 16 states: AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX, WA

Affected (16 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