Optovue recalls

Optovue appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2017-09-06.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• iFusion, Device Listing Number D203271
  FDA Device · Class II · 2017-09-06 · Optovue
• iVue 500 with iScan, D216606
  FDA Device · Class II · 2017-09-06 · Optovue
• iVue with Normative Database, Device Listing Number D185549
  FDA Device · Class II · 2017-09-06 · Optovue
• 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…
  FDA Device · Class II · 2016-04-27 · Optovue
• Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging
  FDA Device · Class III · 2013-06-12 · Optovue
• Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped wit…
  FDA Device · Class II · 2012-10-31 · Optovue