Recall Z-1980-2014— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2014-06-16, terminated 2015-03-03. It names one FDA 510(k) clearance: K113451. Product: 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.. Reason: Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-16
- Terminated
- 2015-03-03
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Data sourced from openFDA. This site is unofficial and independent of the FDA.