Devices

Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12

Model / Serial
Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009; NVE0002; OH00295; NC00185; CAE0016; COE0008; MI00131; GA00241; CAE0007; VAE0004; MI00131; CAE0031; AZ00167; COE0011; CA00561; PAE0003; TN00168; MNE0009; WA00246; CAE0047; OHE0005; WAE0008; MI00244; NY00473; CAE0007; WAE0008; NVE0002; WA00233; CAE0016.
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Product Description
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
Nidek Inc
1 Event
- Recall of Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12

Manufacturer

Nidek Inc

Manufacturer Address
Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
Manufacturer Parent Company (2017)
Nidek Co. Ltd.
Source
USFDA

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