Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported June 12, 2013
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
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 indivi…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Optovue, Inc. recalled Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended… - a low-severity action.
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended… was recalled by Optovue, Inc. in June 12, 2013. Reason: Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version …. Check the official notice for the remedy. Verify recall #Z-1441-2013 with the FDA Devices before acting.
The recall
Optovue, Inc. issued this low-severity FDA Devices recall-Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version ….
- Low
- severity level
- Class III
- classification
- June 12, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1441-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1441-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on May 14, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Optovue, Inc. is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as ~329 users.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distributed Nationwide and in Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
~329 users
Related Recalls
6
3 from same agency
Product description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1441-2013 |
| Date reported | June 12, 2013 |
| Date initiated | May 14, 2013 |
| Recalling firm | Optovue, Inc. |
| Firm location | Fremont, CA |
| Affected scope | ~329 users |
| Distribution | Distributed Nationwide and in Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1441-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.. Recalled by Optovue, Inc.. Units affected: ~329 users.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2013. Severity: Low. Recall number: Z-1441-2013.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide and in Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1441-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 12, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.