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Optovue, Inc. recalls 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
Recalled April 27, 2016 · FDA recall Z-1498-2016 · Optovue
Hazard
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. · FDA Class II
Units
40
Sold at
PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming
Description
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.
Product
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.
Manufacturer(s)
Optovue, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →