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Nidek Inc recalls Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System.
Recalled March 29, 2017 · FDA recall Z-1494-2017 · Nidek
Hazard
During treatment planning, the procedure was programmed with an unintended (wrong) correction. · FDA Class II
Units
29
Sold at
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Description
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Product
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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.
Manufacturer(s)
Nidek Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →