Recall Z-0024-2013 ยท OBO Tomography, Optical Coherence
Optovue Inc.
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 mea
| Date | Oct 9, 2012 (initiated Sep 7, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 795 units |
| Distribution | Worldwide Distribution -- USA (nationwide) and Internationally. |
| FDA record | Open on fda.gov |