Reported Apr 27, 2016 · Terminated
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…
Optovue, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Optovue, Inc. · 2800 Bayview Dr · Fremont, CA · 94538-6518
Is this the product you have?
- 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) OpthalmiciVue 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
- Lot codes and dates
- US and foreign (not yet provided) Software version 2016.0.0.127:
- Serial numbers
21908265072649626558227382613926442257202507925142232982199023461241992584326572265502297126495226522655022971264952265225389233092376021732-12352720923216002141420271231532287523211. Software version 2016.1.0.127Serial numbers forthcoming
- Amount recalled
- 40
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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