Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iVue and iVue 500 (now called iScan) OCT systems with Recalled by Optovue, Inc. Due to A software anomaly was detected that affects Optovue...
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 Optovue, Inc. directly.
Affected Products
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.
Quantity: 40
Why Was This Recalled?
A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.
Where Was This Sold?
This product was distributed to 21 states: AZ, AR, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MO, NE, NV, OK, PA, TN, UT, VA, WV
About Optovue, Inc.
Optovue, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report