FDA-Device2012-10-24Class II
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.
Trumpf Medical Systems, Inc.
Hazard
Incidents regarding fractures of the front joint of the spring arm have been reported.
Sold states
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.
Affected count
275 units
Manufactured in
415 Jessen Ln, N/A, Charleston, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2013Don't want to check this manually?
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