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.
FDA Recall Z-2046-2013 · Posted 2013-08-23
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Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHKI
Date Initiated2013-08-01
Date Terminated2014-02-25
Product Quantity86
Reason for Recall
Under certain circumstances, the Left eye image may be saved as the Right eye image.
Firm Action
"Medical Device Correction Notification" letters dated August 5, 2013 were sent to consignees through their US contracted distributor - Marco Opthalmic. The letter described the product issue and provided information on the correction. Customers can contact 800-223-9044 for questions.
Root Cause
Software design
Distribution Pattern
Nationwide US distribution only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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