Reported Sep 4, 2013 · Terminated

NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file…

Nidek Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474

NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

Lot codes and dates: version 1.1.0
serial numbers
320823
320425
320622
121424
320094
320606
320617
320577
320636
320630
320468
320489
320518
320695
320695
320652
320666
320692
320675
320640
320492
320695
320704
320777
320779
320771
320768
320753
320744
320780
320617; version 1.2.1; serial numbers 320740 120045; Version 1.3.0:
141356
320814
320815
140941
141326
320847
320916
320906
320203
320569
320809
320813
141357
320831
140937
141358
320798
320090
320980
320990
320927
320942
320920
141401
320983; Version 1.3.4; 321035 321020 320998 141453; Version 1.3.5:
380215
380188
380189
380251
380211
380014
380077
380213
380076
380034
380035
380017
380244
380124
380243
380075
380122
380021
380253/380052
380221/380214
141480
141471
321053
320883
Amount recalled: 86

Under certain circumstances, the Left eye image may be saved as the Right eye image.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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14 in total.