Brand

Optovue, Inc. Recalls

5 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Optovue, Inc..

5Total Recalls
0Critical
1,816Units Affected
Jul 27, 2017Most Recent
All Recalls

Every Optovue, Inc. Recall

Sorted by most recent. Click any recall for full details.

5 recalls
High RiskFDA
Optovue, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is sui...
Diagnostic Devices·326 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomo...
Medical Devices·326 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
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:...
Medical Devices·40 affected·Mar 16, 2016
RecallFDA
Optovue, Inc.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Medical Devices·329 affected·May 14, 2013
High RiskFDA
Optovue Inc.
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped w...
Medical Devices·795 affected·Sep 7, 2012