Recall Z-0771-2020 ยท NQE Microscope, Specular
Nidek, Inc.
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.
| Date | Feb 25, 2019 |
| Status | Terminated |
| Reason | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 13 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR. |
| FDA record | Open on fda.gov |