Recall Z-2046-2013— Nidek Inc

Name: FDA recall Z-2046-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-01

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2013-08-01, terminated 2014-02-25. It names one FDA 510(k) clearance: K113451. Product: 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.. Reason: Under certain circumstances, the Left eye image may be saved as the Right eye image..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2013-08-01
Terminated: 2014-02-25
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K113451 — NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXNidek Technologies Srl·cleared 2012-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.