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U.S. Department of Health and Human Services

Class 2 Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database

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  Class 2 Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database see related information
Date Initiated by Firm January 08, 2010
Date Posted March 15, 2010
Recall Status1 Terminated 3 on March 24, 2011
Recall Number Z-1131-2010
Recall Event ID 54191
510(K)Number K091297  
Product Classification Tomography, optical coherence - Product Code OBO
Product 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.
Code Information Serial Numbers from 10005 to 11805 (serial number are sequential)
Recalling Firm/
Manufacturer		 Optovue Inc.
45331 Northport Loop W
Fremont CA 94538-6417
For Additional Information Contact
510-623-8868 Ext. 102
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 1800 units
Distribution Nationwide and Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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