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

  • Modelo / 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.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
  • Descripción del producto
    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
  • 1 Event


  • Dirección del fabricante
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Empresa matriz del fabricante (2017)
  • Source