Z-1498-2016Class II

iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and...

Name: Z-1498-2016 iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and...
Creator: Optovue, Inc.
Published: 2016-03-16
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2016-03-16 / Terminated / root cause: software

FDA source

Optovue, Inc. began a 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 is a non-contact... on 2016-03-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1498-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-16
Posted: 2017-08-14
Terminated: 2017-04-04
Recalling firm: Optovue Inc.
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.
Product code: HLI Ophthalmoscope, Ac-Powered
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Recall Letters were sent to customers on March 22, 2016 to inform them of the recall.
Quantity in commerce: 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
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1498-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1498-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15

Product code HLI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)