Reported Dec 18, 2013 · Terminated

Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with…

Trumpf Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trumpf Medical Systems, Inc. · 415 Jessen Ln · Charleston, SC · 29492-7906

Is this the product you have?

  • 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.
Lot codes and dates
  • Unknown
Amount recalled
287

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 6, 2017 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.