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Class 2 Device Recall Optovue iVue and iVue 500 |
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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
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Product Classification |
Ophthalmoscope, ac-powered - Product Code HLI
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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
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For Additional Information Contact |
Edward J. Sinclair 510-897-1575
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HLI and Original Applicant = OPTOVUE, INC.
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