Recall Z-1498-2016
Optovue, Inc. · initiated March 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: US and foreign (not yet provided) Software version 2016.0.0.127: Serial numbers: 21908, 26507, 26496, 26558, 22738, 26139, 26442, 25720, 25079, 25142, 23298, 21990, 23461, 24199, 25843, 26572, 26550, 22971, 26495, 22652, 26550, 22971, 26495, 22652, 25389, 23309, 23760, 21732-1, 23527, 20923, 21600, 21414, 20271, 23153, 22875, 23211. Software version 2016.1.0.127; Serial numbers forthcoming.
Reason for recall
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-determined cause: Under Investigation by firm
Action taken
Recall Letters were sent to customers on March 22, 2016 to inform them of the recall.
Details
- Recall number
- Z-1498-2016
- Initiated
- March 16, 2016
- Terminated
- April 4, 2017
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Quantity
- 40
- Distribution
- 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
- Recalling firm
- Optovue, Inc., Fremont, CA