Nidek Inc

Complete recall history across all FDA and CPSC categories — 18 total recalls

Nidek Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Nidek Inc

Date Product Reason Class
Feb 1, 2017 Final Fit Software Version 1.11 and 1.12; PC Based software installed outsi... During treatment planning, the procedure was programmed with an unintended (w... Class II
Aug 8, 2016 SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a... Class II
Jul 1, 2016 OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... Nidek Inc. received information from our manufacturer NIDEK CO. Japan that t... Class II
Feb 29, 2016 RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instr... There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refracto... Class II
Jun 15, 2015 OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1... Software bug was found where there was no difference in Total and Corneal hig... Class II
Mar 25, 2015 Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:... Accessories to the GYC-1000 laser were missing Laser Aperture labels. Class II
Mar 25, 2015 Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator S... Accessories to the GYC-1000 laser were missing Laser Aperture labels. Class II
Mar 24, 2015 EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000... Multi-stage treatment option for the EC-5000 Operator's Manual was not approv... Class II
Mar 6, 2015 YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and blood... Dear Doctor letter and Quick Reference Guide is being sent to users of the YC... Class II
Jun 16, 2014 Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for us... Image taken by AFC-330 has a white spot which may affect diagnosis or evaluat... Class II
Jun 9, 2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufact... Laser aperture label was not affixed to device prior to shipment in the US. Class II
Jun 9, 2014 RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: ... Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneousl... Class II
May 16, 2014 GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoa... Class II
Aug 1, 2013 NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.... Under certain circumstances, the Left eye image may be saved as the Right eye... Class II
May 24, 2013 MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... Retrospective review found that a Engineering Change Order initiated in May 2... Class II
Oct 24, 2012 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... When the MC-500 is turned on and coagulation is performed without changing th... Class II
Aug 6, 2012 Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic D... Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII E... Class II
Mar 27, 2012 MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal phot... The spot size control of the scan delivery unit of the MC-500 Multicolor Lase... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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