Nidek recalls
Nidek appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2020-01-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 21 |
|---|---|
| Published | 2013-09-04 to 2020-01-08 |
| By agency | FDA Device (21) |
| By classification | Class II (19), Class III (2) |
| By status | terminated (21) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium e…
FDA Device · Class III · 2020-01-08 · Nidek
Reason: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) - RT-5100 Refractor, a component of the Epic-5100 System
FDA Device · Class III · 2018-12-26 · Nidek
Reason: The lens bonding was incomplete on the refractor. - AUTO REF/KERATOMETER ARK-1s
FDA Device · Class II · 2018-04-18 · Nidek
Reason: There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek
Reason: During treatment planning, the procedure was programmed with an unintended (wrong) correction. - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek
Reason: Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. - OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
FDA Device · Class II · 2016-08-24 · Nidek
Reason: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement. - RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical len…
FDA Device · Class II · 2016-03-30 · Nidek
Reason: There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient. - 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 1.07.0…
FDA Device · Class II · 2015-09-02 · Nidek
Reason: Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. - Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indic…
FDA Device · Class II · 2015-07-22 · Nidek
Reason: Accessories to the GYC-1000 laser were missing Laser Aperture labels. - Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System
FDA Device · Class II · 2015-07-22 · Nidek
Reason: Accessories to the GYC-1000 laser were missing Laser Aperture labels. - EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest
FDA Device · Class II · 2015-06-10 · Nidek
Reason: Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. - YC-1800 OPHTHALMIC YAG LASER SYSTEM
FDA Device · Class II · 2015-04-08 · Nidek
Reason: Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images. - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2015-02-25 · Nidek
Reason: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. - MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek
Reason: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. - Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek
Reason: When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. - Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device
FDA Device · Class II · 2014-11-26 · Nidek
Reason: Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient. - GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgic…
FDA Device · Class II · 2014-08-20 · Nidek
Reason: Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation, - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2014-08-06 · Nidek
Reason: Laser aperture label was not affixed to device prior to shipment in the US. - Non-Mydriatic Auto Fundus Camera
FDA Device · Class II · 2014-07-09 · Nidek
Reason: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. - RT-5100 Refractor and RT-3100 Refractor
FDA Device · Class II · 2014-07-02 · Nidek
Reason: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. - 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 software…
FDA Device · Class II · 2013-09-04 · Nidek
Reason: Under certain circumstances, the Left eye image may be saved as the Right eye image.