Company: Nidek Inc
Date of Enforcement Report 9/7/2016
Class lI:
PRODUCT
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, 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,
Recall Number Z-2711-2016
REASON
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
RECALLING FIRM/MANUFACTURER
Nidek Inc., Fremont, CA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
29 devices
DISTRIBUTION
Nationwide
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