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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Recall Number Z-1441-2013
Classification Class III
Code Info 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.
Product Distributed Qty ~329 users
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.

Event Detail

Event Id 65191
Product Type Devices
Status Ongoing
Recalling Firm Optovue, Inc.
City Fremont
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed Nationwide and in Canada.