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Trumpf Medical Systems, Inc. recalls Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body wi
Recalled December 18, 2013 · FDA recall Z-0484-2014 · Trumpf Medical Systems
Hazard
Possible fatigue failure of the plastic joint may occur after an average use of seven years. · FDA Class II
Units
287
Sold at
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Description
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Product
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.
Manufacturer(s)
Trumpf Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →