Sep

2016

Nidek SPECULAR MICROSCOPE CEM-530 Cl II

Company: Nidek Inc
Date of Enforcement Report 9/7/2016
Class lI:

PRODUCT

SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, 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 Number Z-2711-2016

REASON
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.

RECALLING FIRM/MANUFACTURER
Nidek Inc., Fremont, CA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 devices

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Nidek SPECULAR MICROSCOPE CEM-530 Cl II

Amy Sellers

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