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 management of retinal disease.
Recall
- Recall Number
- Z-1131-2010
- Event Number
- 54191
- Firm
- Optovue Inc.
- FEI Number
- 3005950902
- Product Code
- OBO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 8, 2010
- Posted
- March 15, 2010
- Terminated
- March 24, 2011
- Address
- 45331 Northport Loop W, Fremont, CA, 94538-6417
Description
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 management of retinal disease.
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.
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.
Nationwide and Worldwide
1800 units