NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is ind...

FDA Device Recall #Z-2046-2013 — Class II — August 1, 2013

Recall Summary

Recall Number Z-2046-2013
Classification Class II — Moderate risk
Date Initiated August 1, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nidek Inc
Location Fremont, CA
Product Type Devices
Quantity 86

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.

Distribution Pattern

Nationwide US distribution only.

Lot / Code Information

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.

Other Recalls from Nidek Inc

Recall # Classification Product Date
Z-1494-2017 Class II Final Fit Software Version 1.11 and 1.12; PC ... Feb 1, 2017
Z-2711-2016 Class II SPECULAR MICROSCOPE CEM-530; Software version 1... Aug 8, 2016
Z-2587-2016 Class II OPTICAL BIOMETER AL-Scan: Software Version: 1.0... Jul 1, 2016
Z-1245-2016 Class II RT-5100 (Epic 5100) Refractor and RT 3100 Refra... Feb 29, 2016
Z-2477-2015 Class II OPD-Scan III Refractive Power/Corneal Analyzer ... Jun 15, 2015

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.