Z-1441-2013Class III

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

Name: Z-1441-2013 Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging
Creator: Optovue, Inc.
Published: 2013-05-14
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2013-05-14 / Terminated / root cause: software

FDA source

Optovue, Inc. began a recall of Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging on 2013-05-14. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1441-2013
Classification: Class III
Status: Terminated
Initiated: 2013-05-14
Posted: 2013-05-31
Terminated: 2013-10-24
Recalling firm: Optovue Inc.
Product: Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Product code: HLI Ophthalmoscope, Ac-Powered
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.
Root cause tag: software
FDA root cause: Software design
Action: Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: ~329 users
Distribution: Distributed Nationwide and in Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1441-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1441-2013	Class III	Terminated	Voluntary: Firm initiated	2013-06-12	2013-05-31

Product code HLI

K121739Class IIIvue with Normative DatabaseOptovue, Inc. / cleared 2013-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)