Recall Z-1131-2010 ยท OBO Tomography, Optical Coherence
Optovue Inc.
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue 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 managem
| Date | Mar 15, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | Marketed without proper 510(k)-- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database. |
| Root cause | Other |
| Action | The firm is preparing a software "Roll Back" version of software to disable the NDB and other features, ensuring that this version will work properly. A customer notification letter is provided as well as a correction verification form, installation instructions and user manual. If there are any questions, please call 1-866-344-8948. |
| Quantity | 1800 units |
| Distribution | Nationwide and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.