Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NAVIS-EX Recalled by Nidek Inc Due to Under certain circumstances, the Left eye image may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
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.
Quantity: 86
Why Was This Recalled?
Under certain circumstances, the Left eye image may be saved as the Right eye image.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report