Events

Recall of NAVISEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nidek Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65865
  • Event Risk Class
    Class 2
  • Event Number
    Z-2046-2013
  • Event Initiated Date
    2013-08-01
  • Event Date Posted
    2013-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120548
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, ophthalmic, ac-powered - Product Code HKI
  • Reason
    Under certain circumstances, the left eye image may be saved as the right eye image.
  • 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.

Device

NAVISEX
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide US distribution only.
  • 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.
  • Manufacturer
    Nidek Inc

Manufacturer

Nidek Inc
  • Manufacturer Address
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Manufacturer Parent Company (2017)
    Nidek Co. Ltd.
  • Source
    USFDA