Fremont, CA, United States
Nidek Inc. recalls
3 recalls recorded since 2018, most recently on 25 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 25 February 2019
- Terminated
- 15 June 2021
- Reason
- The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
- Distribution
- US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0771-2020
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the numbe
Terminated Class III Medical devices
- Recall started
- 14 June 2018
- Terminated
- 3 June 2020
- Reason
- The lens bonding was incomplete on the refractor.
- Distribution
- Distribution was made to FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0655-2019
- RT-5100 Refractor, a component of the Epic-5100 System.
Terminated Class II Medical devices
- Recall started
- 20 December 2017
- Terminated
- 18 March 2019
- Reason
- There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
- Distribution
- Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1348-2018
- AUTO REF/KERATOMETER ARK-1s
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.