Optovue, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1441-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

Product Classification:

Class III

Date Initiated: May 14, 2013

Date Posted: June 12, 2013

Recall Number: Z-1441-2013

Event ID: 65191

Reason for Recall:

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.

Status: Terminated

Product Quantity: ~329 users

Code Information:

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.

Distribution Pattern:

Distributed Nationwide and in Canada.

Voluntary or Mandated:

Voluntary: Firm initiated