Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and ante
FDA device recall Z-1980-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
- Action taken
- Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HKI
- Quantity affected
- 185 cameras
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-06-16
- Date posted
- 2014-07-02
- Date terminated
- 2015-03-03
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX (K113451) | Nidek Technologies Srl | 2012-05-08 |