Recall Z-1441-2013
Optovue, Inc. · initiated May 14, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Codes / lots: 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.
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: Software design
Action taken
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.
Details
- Recall number
- Z-1441-2013
- Initiated
- May 14, 2013
- Posted by FDA
- May 31, 2013
- Terminated
- October 24, 2013
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Quantity
- ~329 users
- Distribution
- Distributed Nationwide and in Canada.
- Recalling firm
- Optovue, Inc., Fremont, CA