Recall Z-2046-2013
Nidek Inc · initiated August 1, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Under certain circumstances, the Left eye image may be saved as the Right eye image.
FDA-determined cause: Software design
Action taken
"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.
Details
- Recall number
- Z-2046-2013
- Initiated
- August 1, 2013
- Posted by FDA
- August 23, 2013
- Terminated
- February 25, 2014
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Quantity
- 86
- Distribution
- Nationwide US distribution only.
- Recalling firm
- Nidek Inc, Fremont, CA