Brand

Nidek Inc. Recalls

12 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Nidek Inc..

12Total Recalls
0Critical
5,170Units Affected
Feb 25, 2019Most Recent
All Recalls

Every Nidek Inc. Recall

Sorted by most recent. Click any recall for full details.

12 recalls
RecallFDA
Nidek, Inc.
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium...
Medical Devices·13 affected·Feb 25, 2019
RecallFDA
Nidek Inc.
RT-5100 Refractor, a component of the Epic-5100 System.
Medical Devices·85 affected·Jun 14, 2018
High RiskFDA
Nidek Inc.
AUTO REF/KERATOMETER ARK-1s
Medical Devices·63 affected·Dec 20, 2017
High RiskFDA
Nidek Inc
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, hi...
Medical Devices·29 affected·Aug 8, 2016
High RiskFDA
Nidek Inc
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can ...
Medical Devices·17 affected·Jul 1, 2016
High RiskFDA
Nidek Inc
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.0...
Diagnostic Devices·3,836 affected·Jun 15, 2015
High RiskFDA
Nidek Inc
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green...
Surgical Devices·20 affected·Mar 25, 2015
High RiskFDA
Nidek Inc
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by m...
Medical Devices·799 affected·Mar 6, 2015
High RiskFDA
Nidek Inc
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of ...
Medical Devices·185 affected·Jun 16, 2014
High RiskFDA
Nidek Inc
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management softwa...
Medical Devices·86 affected·Aug 1, 2013
High RiskFDA
Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator ...
Medical Devices·21 affected·Oct 24, 2012
High RiskFDA
Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like di...
Medical Devices·16 affected·Mar 27, 2012