Recall Z-1980-2014 ยท HKI Camera, Ophthalmic, Ac-Powered
Nidek Inc
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
| Date | Jul 2, 2014 (initiated Jun 16, 2014) |
| Status | Terminated |
| Reason | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| Root cause | Device Design |
| Action | Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method. |
| Quantity | 185 cameras |
| Distribution | Nationwide Distribution. |
| 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 |