FDA Device recall Z-1498-2016
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…
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of 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… by Optovue, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1498-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-16 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Optovue |
| Distribution | AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MO, NE, NV, OK, PA, TN, UT, VA, WV |
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.
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.
Identifiers
| code_info | US and foreign (not yet provided) Software version 2016.0.0.127: Serial numbers: 21908, 26507, 26496, 26558, 22738…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1498-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.