FDA Enforcement
Class III
Terminated
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.
Recall: Z-0771-2020
·
Reported January 8, 2020
Enforcement
- Recall Number
- Z-0771-2020
- Event ID
- 84112
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nidek, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 8, 2020
- Initiation Date
- February 25, 2019
- Classification Date
- January 2, 2020
- Termination Date
- June 15, 2021
- Address
- 47651 Westinghouse Dr, N/A, Fremont, CA, 94539-7474, United States
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
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Code Info
Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.
Distribution
US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Quantity
13 devices