Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina
FDA device recall Z-0024-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Optovue Inc.
- 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.
- Action taken
- Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer . Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. If you have any further questions please contact Optovue, at 1-866-344-8948.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- OBO
- Quantity affected
- 795 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and Internationally.
- Date initiated
- 2012-09-07
- Date posted
- 2012-10-09
- Date terminated
- 2013-03-04
- Location
- Fremont, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RTVUE MODEL RTVUE 100 (K101505) | Optovue, Inc. | 2010-09-15 |
| IVUE, MODEL 100 (K091404) | Optovue, Inc. | 2010-04-22 |