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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