Nidek SA
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000000493
Part of Nidek, Inc.
- Devices
- 13
- Registrations
- EUDAMED
- FDA recalls
- 21
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
What Nidek SA makes
NIDEK SA manufactures ophthalmic examination equipment, including electrically powered height-adjustable tables, motorised and fixed-height consultation platforms, and consultation units designed for eye care assessments. Their portfolio also includes examination chairs, automated refractor control software, and diagnostic devices such as the OT-4200 and OT-6400 for retinal imaging and testing. Additional offerings include standalone consultation units like SYNETIC, LYPOP, and AFFINITY, as well as compact examination solutions such as the UP Mini.
All listed devices fall under Class I of the EU Medical Device Regulation, and they are registered in the EU’s eudamed database. The company is headquartered in France, where its products are authorised for use within the European market.
Catalogue
Search and filter all 13 devicesCompany details
- EUDAMED SRN
- FR-MF-000000493
- EU VAT number
- FR89344082144
- EUDAMED status
- Active
- EUDAMED registered name
- NIDEK SA
- Registered address
- 9, Rue Benjamin Franklin, 94370, SUCY-EN-BRIE, France
- Website
- www.nidek.fr
- facebook.com/NIDEK.SA
- [email protected]
- Phone
- +33 1 49 80 97 97
- PRRC contact
- MENTION Agnès
FDA recalls
FDA recall records list 21 recalls initiated by NIDEK SA, the earliest on 2012-03-27 and the most recent on 2019-02-25. By recorded status: 21 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 1
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 25 Feb 2019 Z-0771-2020 Class III Terminated The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
2018
- 14 Jun 2018 Z-0655-2019 Class III Terminated The lens bonding was incomplete on the refractor.
2017
- 20 Dec 2017 Z-1348-2018 Class II Terminated There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Full distribution text
- 1 Feb 2017 Z-1494-2017 Class II Terminated During treatment planning, the procedure was programmed with an unintended (wrong) correction.
- 20 Dec 2017 Z-1348-2018 Class II Terminated There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
2016
- 8 Aug 2016 Z-2711-2016 Class II Terminated 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.
- 1 Jul 2016 Z-2587-2016 Class II Terminated Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
- 29 Feb 2016 Z-1245-2016 Class II Terminated 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.
2015
- 15 Jun 2015 Z-2477-2015 Class II Terminated 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.
- 25 Mar 2015 Z-2067-2015 Class II Terminated Accessories to the GYC-1000 laser were missing Laser Aperture labels.
- 25 Mar 2015 Z-2068-2015 Class II Terminated Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Show all 21 recalls
2015
- 24 Mar 2015 Z-1710-2015 Class II Terminated Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
- 6 Mar 2015 Z-1367-2015 Class II Terminated 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.
2014
- 16 Jun 2014 Z-1980-2014 Class II Terminated Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
- 9 Jun 2014 Z-1853-2014 Class II Terminated Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
- 9 Jun 2014 Z-2132-2014 Class II Terminated Laser aperture label was not affixed to device prior to shipment in the US.
- 16 May 2014 Z-2120-2014 Class II Terminated Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
2013
- 1 Aug 2013 Z-2046-2013 Class II Terminated Under certain circumstances, the Left eye image may be saved as the Right eye image.
- 24 May 2013 Z-0222-2015 Class II Terminated Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
2012
- 24 Oct 2012 Z-0224-2015 Class II Terminated 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.
- 6 Aug 2012 Z-0223-2015 Class II Terminated 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.
- 27 Mar 2012 Z-1127-2015 Class II Terminated The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Frequently asked questions
How many devices does NIDEK SA have in the registry?
The registry currently lists 13 devices for NIDEK SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list NIDEK SA's devices?
Among its 13 most recently registered devices, NIDEK SA has devices listed in EUDAMED (13 devices).
What risk classes do NIDEK SA's devices fall under?
Among its 13 most recently registered devices, the classes recorded for NIDEK SA's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for NIDEK SA?
FDA recall records list 21 recalls initiated by NIDEK SA, the most recent initiated on 2019-02-25. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from NIDEK SA in the registry?
The most recently registered devices listed for NIDEK SA include UP, Table à élévation électrique UP, Unité de consultation SYNETIC and ONE-I Plateau à élévation motorisée.