FDAFDA · Food and drugs·Recall number Z-1441-2013
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Published June 12, 2013 · Recall initiated: May 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Optovue, Inc.
- Distributor
- Distributed Nationwide and in Canada.
- Lot
- iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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