Home / Recalls / Optovue, Inc. / Z-1441-2013

Z-1441-2013 Class III Terminated

Recalled by Optovue, Inc. — Fremont, CA

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.

Other recalls by Optovue, Inc.

  • Z-0009-2018 Class II — iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-con (July 27, 2017)
  • Z-0008-2018 Class II — iVue with Normative Database, Device Listing Number D185549. Product Usage: (July 27, 2017)
  • Z-0010-2018 Class II — iVue 500 with iScan, D216606. Product non-contact, high resolution tomograph (July 27, 2017)
  • Z-1498-2016 Class II — iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0. (March 16, 2016)
  • Z-0024-2013 Class II — Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped wit (September 7, 2012)