Nidek Inc recalls

13 recalls on record · latest: February 25, 2019

Official U.S. recall history for Nidek Inc, compiled from official government records.

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Nidek, Inc. recalls NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capt…

February 25, 2019 · Medical device recalls The electromagnetic noise exceeded the upper limit of the Electromagnetic Compa…

Nidek Inc. recalls RT-5100 Refractor, a component of the Epic-5100 System.

June 14, 2018 · Medical device recalls The lens bonding was incomplete on the refractor.

Nidek Inc. recalls AUTO REF/KERATOMETER ARK-1s

December 20, 2017 · Medical device recalls Moderate risk There is possibly a difference between the measured dioptric value of the subje…

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

February 1, 2017 · Medical device recalls Moderate risk During treatment planning, the procedure was programmed with an unintended (wro…

Nidek Inc recalls SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides…

August 8, 2016 · Medical device recalls Moderate risk Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a c…

Nidek Inc recalls OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring d…

July 1, 2016 · Medical device recalls Moderate risk Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the…

Nidek Inc recalls RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical…

February 29, 2016 · Medical device recalls Moderate risk There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor…

Nidek Inc recalls 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 1.1…

June 15, 2015 · Medical device recalls Moderate risk Software bug was found where there was no difference in Total and Corneal high-…

Nidek Inc recalls Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; T…

March 25, 2015 · Medical device recalls Moderate risk Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Nidek Inc recalls Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Mode…

March 25, 2015 · Medical device recalls Moderate risk Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Nidek Inc recalls EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER COR…

March 24, 2015 · Medical device recalls Moderate risk Multi-stage treatment option for the EC-5000 Operator's Manual was not approved…

Nidek Inc recalls YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for ou…

March 6, 2015 · Medical device recalls Moderate risk Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1…

Nidek Inc recalls MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus d…

March 27, 2012 · Medical device recalls Moderate risk The spot size control of the scan delivery unit of the MC-500 Multicolor Laser…