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Optovue, Inc. recalls Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Recalled June 12, 2013 · FDA recall Z-1441-2013 · Optovue
Hazard
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports. · FDA Class III
Units
~329 users
Sold at
Distributed Nationwide and in Canada.
Description
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Product
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Manufacturer(s)
Optovue, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →