iVue and iVue 500 — Class II medical device recall Z-1498-2016
Terminated recall by Optovue, Inc., reported 2016-04-27, distributed in AR, AZ, CA, CO, FL, GA, HI, IL…. A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may displa
| Recall number | Z-1498-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Optovue, Inc., Fremont, CA, United States |
| Recall initiated | 2016-03-16 |
| Classified | 2016-04-15 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-04-04 |
| Distributed | AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, LA, ME, MO, NE, NV, OK, PA, TN, UT, VA, WV |
| Quantity | 40 |
| Reason classes | software |
| Serial numbers | 20271, 20923, 21414, 21600, 21732-1, 21908, 21990, 22652, 22738, 22875, 22971, 23153, 23211, 23298, 23309, 23461, 23527, 23760, 24199, 25079, 25142, 25389, 25720, 25843, 26139 and 7 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1498-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.