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U.S. Department of Health and Human Services

Class 2 Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12

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 Class 2 Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12see related information
Date Initiated by FirmFebruary 01, 2017
Create DateMarch 20, 2017
Recall Status1 Terminated 3 on December 05, 2017
Recall NumberZ-1494-2017
Recall Event ID 76376
PMA NumberP970053 
Product Classification Excimer laser system - Product Code LZS
ProductFinal 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.
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.               
Recalling Firm/
Manufacturer		 Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information ContactPreeti Gandhi
510-353-7718
Manufacturer Reason
for Recall		During treatment planning, the procedure was programmed with an unintended (wrong) correction.
FDA Determined
Cause 2		Software change control
ActionNidek 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 ff_support@nidek.com.
Quantity in Commerce29
DistributionNationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LZS
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