FDA Devices recall · Reported October 31, 2012
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye sc
Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and…
Optovue Inc. recalled Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue Sy… - a moderate-severity action.
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue Sy… was recalled by Optovue Inc. in October 31, 2012. Reason: Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" po…. Check the official notice for the remedy. Verify recall #Z-0024-2013 with the FDA Devices before acting.
The recall
Optovue Inc. issued this moderate-severity FDA Devices recall-Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" po….
- Moderate
- severity level
- 795 units
- affected scope
- Class II
- classification
- October 31, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0024-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
Reason for recall
Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0024-2013 |
| Date reported | October 31, 2012 |
| Date initiated | September 7, 2012 |
| Recalling firm | Optovue Inc. |
| Firm location | Fremont, CA |
| Affected scope | 795 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and Internationally. |
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-0024-2013) 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.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
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Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026