Reported Jul 9, 2014 · Terminated
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- 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.
- Lot codes and dates
- Model AFC-330Serial
- numbers
185 of 185 codes
380034380021380035380061380060380013380011380069380073380053380055380067380077380078380017380075380032380080380081380092380116380120380237380238380239380240380241380122380121380014380211380125380126380127380124380215380214380188380221380187380190380189380212380062380038380128380223380224380076380216380213380222380243380054380042380225380244380251380252380256
- Amount recalled
- 185 cameras
Where it was sold
- Nationwide
Why it was recalled
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
This product could cause temporary or reversible health problems — stop using it.
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