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Trumpf Medical Systems, Inc. recalls Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate
Recalled October 24, 2012 · FDA recall Z-0077-2013 · Trumpf Medical Systems
Hazard
Incidents regarding fractures of the front joint of the spring arm have been reported. · FDA Class II
Units
275 units
Sold at
Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
Description
Incidents regarding fractures of the front joint of the spring arm have been reported.
Product
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.
Manufacturer(s)
Trumpf Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →