Z-1441-2013 Class III Terminated
FDA device recall Z-1441-2013 was initiated by Optovue, Inc. on May 14, 2013 and is designated Class III. 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… The recall status is terminated (terminated October 24, 2013). Affected quantity: ~329 users.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- May 14, 2013
- Termination Date
- October 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ~329 users
Product Description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
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.
Distribution Pattern
Distributed Nationwide and in Canada.
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.