NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact recall — FDA Z-0771-2020
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Overview of recall records associated with Nidek, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 1, Class II: 1.
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
This page summarizes recall records in which the official source identifies Nidek, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.