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.
This recall has been terminated (originally issued February 25, 2019).
- Company
- Nidek Inc
- Recall Initiated
- February 25, 2019
- Terminated
- June 15, 2021
- Recall Number
- Z-0771-2020
- Quantity
- 13 devices
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.
Root Cause
Device Design
Action Taken
The recalling firm issued letters dated 2/7/2019 via FedEx explaining the issue, informing the consignee there was no risk associated with use of the device, and that the firm is preparing for the replacement parts in order to schedule for the correction to be made.
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