Z-0771-2020 Class III Terminated
FDA device recall Z-0771-2020 was initiated by Nidek, Inc. on February 25, 2019 and is designated Class III. Reason for recall: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) The recall status is terminated (terminated June 15, 2021). Affected quantity: 13 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2020
- Initiation Date
- February 25, 2019
- Termination Date
- June 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
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)
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Code Information
Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.