Image Filing Software, Cl ll NAVIS-EX

Company: Nidek Inc.
Date of Enforcement Report: 9/4/2013
Class ll:

PRODUCT

NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Recall Number Z-2046-2013

REASON
Under certain circumstances, the Left eye image may be saved as the Right eye image.

RECALLING FIRM/MANUFACTURER
Nidek Inc., on 8/1/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
86

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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Image Filing Software, Cl ll NAVIS-EX

Amy Sellers

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