Company: Nidek Inc.
Date of Enforcement Report: 9/4/2013
Class ll:
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.
Recall Number Z-2046-2013
REASON
Under certain circumstances, the Left eye image may be saved as the Right eye image.
RECALLING FIRM/MANUFACTURER
Nidek Inc., on 8/1/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
86
DISTRIBUTION
Nationwide
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