Recall Z-1498-2016 ยท HLI Ophthalmoscope, Ac-Powered
Optovue, Inc.
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,
| Date | Mar 16, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Recall Letters were sent to customers on March 22, 2016 to inform them of the recall. |
| 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 |
| FDA record | Open on fda.gov |