FDA-Device2014-11-26Class II
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Nidek Inc
Hazard
Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.
Sold states
US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.
Affected count
14 units
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2015Don't want to check this manually?
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