Recall Z-0771-2020— Nidek, Inc.
Class III · Terminated
Class III FDA medical device recall by Nidek, Inc., initiated 2019-02-25, terminated 2021-06-15. It names 3 FDA 510(k) clearances: K173980, K151706, K130565. Product: 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 number of endothelial cells, cell density, and cell area is analyzed through the captured images.. Reason: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2).
- Recalling firm
- Nidek, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-02-25
- Terminated
- 2021-06-15
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K173980 — Specular Microscope CEM-530
- K151706 — Specular Microscope CEM- 530
- K130565 — SPECULAR MICROSCOPE CEM-530
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Reason for recall
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Data sourced from openFDA. This site is unofficial and independent of the FDA.