Recall Z-2046-2013 ยท HKI Camera, Ophthalmic, Ac-Powered
Nidek Inc
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.
| Date | Aug 23, 2013 (initiated Aug 1, 2013) |
| Status | Terminated |
| Reason | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
| Root cause | Software design |
| 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. |
| Quantity | 86 |
| Distribution | Nationwide US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX Nidek Technologies Srl, May 8, 2012 |