Reported Jan 8, 2020 · Terminated
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image…
Nidek, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- NIDEK Specular Microscope
- Model CEM-530 - Product UsageThe device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images
- Lot codes and dates
Serial numbers 120080120081120086120087120088120090120091120092120093120094120095120096and 170001
- Amount recalled
- 13 devices
Where it was sold
Why it was recalled
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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