Home / Recalls / Optovue, Inc. / Z-1498-2016

Z-1498-2016 Class II Terminated

Recalled by Optovue, Inc. — Fremont, CA

Recall Details

Product Type
Devices
Report Date
April 27, 2016
Initiation Date
March 16, 2016
Termination Date
April 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40

Product Description

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.

Distribution Pattern

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

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.

Other recalls by Optovue, Inc.

  • Z-0009-2018 Class II — iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-con (July 27, 2017)
  • Z-0008-2018 Class II — iVue with Normative Database, Device Listing Number D185549. Product Usage: (July 27, 2017)
  • Z-0010-2018 Class II — iVue 500 with iScan, D216606. Product non-contact, high resolution tomograph (July 27, 2017)
  • Z-1441-2013 Class III — Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. (May 14, 2013)
  • Z-0024-2013 Class II — Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped wit (September 7, 2012)