Nidek Inc: Medical Device Recall in 2017 - (Recall #: Z-1494-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 1, 2017

Date Posted: March 29, 2017

Recall Number: Z-1494-2017

Event ID: 76376

Reason for Recall:

During treatment planning, the procedure was programmed with an unintended (wrong) correction.

Status: Terminated

Product Quantity: 29

Code Information:

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.

Distribution Pattern:

Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.

Voluntary or Mandated:

Voluntary: Firm initiated