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.
FDA Recall Z-0771-2020 · Posted None
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Recalling FirmNidek, Inc.
Recall StatusTerminated
Product CodeNQE
Date Initiated2019-02-25
Date Terminated2021-06-15
Product Quantity13 devices
Reason for Recall
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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