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
FDA device recall Z-2046-2013 · posted 2013-08-23 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Under certain circumstances, the Left eye image may be saved as the Right eye image.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HKI
- Quantity affected
- 86
- Distribution
- Nationwide US distribution only.
- Date initiated
- 2013-08-01
- Date posted
- 2013-08-23
- Date terminated
- 2014-02-25
- 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 |