Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SPECULAR MICROSCOPE CEM-530 Recalled by Nidek Inc Due to Software version 1.08 and 1.09 for the Specular...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
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. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
Quantity: 29 affected devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 18 states: AL, CA, CT, FL, IN, KS, KY, LA, MO, NV, NM, NY, OK, OR, PA, TN, TX, VA
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report