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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nidek Inc
- Reason for Recall:
- Under certain circumstances, the Left eye image may be saved as the Right eye image.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2046-2013
Related Recalls
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
The lens bonding was incomplete on the refractor.
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.