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Class 2 Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12 |
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Date Initiated by Firm |
February 01, 2017 |
Create Date |
March 20, 2017 |
Recall Status1 |
Terminated 3 on December 05, 2017 |
Recall Number |
Z-1494-2017 |
Recall Event ID |
76376 |
PMA Number |
P970053 |
Product Classification |
Excimer laser system - Product Code LZS
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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. |
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
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For Additional Information Contact |
Preeti Gandhi 510-353-7718
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Manufacturer Reason for Recall |
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
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FDA Determined Cause 2 |
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 ff_support@nidek.com. |
Quantity in Commerce |
29 |
Distribution |
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY. |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LZS and Original Applicant = NIDEK CO., LTD.
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