Z-1494-2017Class II

Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser...

Name: Z-1494-2017 Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser...
Creator: Nidek Inc
Published: 2017-02-01
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2017-02-01 / Terminated / root cause: software

FDA source

Nidek Inc began a recall of 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... on 2017-02-01. FDA classified it as Class II and gives the reason as "During treatment planning, the procedure was programmed with an unintended (wrong) correction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1494-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Posted: 2017-03-20
Terminated: 2017-12-05
Recalling firm: Nidek Incorporated
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.
Product code: LZS Excimer Laser System
Reason for recall: During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Root cause tag: software
FDA root cause: Software change control
Action: Nidek sent a Recall notification letter dated February 1, 2017 to all affected consignees by certified mail method beginning February 2, 2017. Letters advised of the issue received from a complaint and the steps the user took that created the issue. To prevent the issue, the letters provide steps that should be taken. Nidek's Customer Support team will contact customers by phone or email. Customers with questions were instructed to contact Customer Service at 1-800-223-9044 or email [email protected].
Quantity in commerce: 29
Distribution: Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1494-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1494-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code LZS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)