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U.S. Department of Health and Human Services

Class 3 Device Recall Optovue iVue with Normative Database

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 Class 3 Recall
Optovue iVue with Normative Database
see related information
Date Posted May 31, 2013
Recall Status1 Terminated on October 24, 2013
Recall Number Z-1441-2013
Recall Event ID 65191
Premarket Notification
510(K) Number
K121739 
Product Classification Ophthalmoscope, Ac-Powered - Product Code HLI
Product Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Code Information iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
Recalling Firm/
Manufacturer
Optovue, Inc.
2800 Bayview Dr
Fremont, California 94538-6518
For Additional Information Contact William Jackson
510-623-8868 Ext. 102
Manufacturer Reason
for Recall
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
FDA Determined
Cause 2
DESIGN: Software Design
Action Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce ~329 users
Distribution Distributed Nationwide and in Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HLI and Original Applicant = OPTOVUE, INC.
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