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U.S. Department of Health and Human Services

Class 2 Device Recall Optovue iVue and iVue 500

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  Class 2 Device Recall Optovue iVue and iVue 500 see related information
Date Initiated by Firm March 16, 2016
Create Date August 14, 2017
Recall Status1 Terminated 3 on April 04, 2017
Recall Number Z-1498-2016
Recall Event ID 73612
510(K)Number K133892  K121739  
Product Classification Ophthalmoscope, ac-powered - Product Code HLI
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Optovue, Inc.
2800 Bayview Dr
Fremont CA 94538-6518
For Additional Information Contact Edward J. Sinclair
510-897-1575
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HLI and Original Applicant = OPTOVUE, INC.
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