Nidek CEM-530 Microscope Recall: Electromagnetic Noise Risk

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Contact the company & request your remedy

Recalling firmNidek, Inc.47651 Westinghouse Dr, N/A · Fremont, CA 94539-7474

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Nidek is recalling its CEM-530 Specular Microscopes because electromagnetic noise exceeds safety limits. This could cause interference with other medical devices, but it does not pose a direct risk of injury to users.

Why it’s dangerous

The microscope's electromagnetic noise exceeds the safety standard (IEC 60601-1-2), which could interfere with other medical equipment. However, this does not cause physical harm to users or patients.

Who’s affected

Medical professionals using the Nidek CEM-530 Specular Microscope for eye examinations are most at risk. Patients using the device are not directly affected by the electromagnetic issue.

How to tell if you have this one

Check for serial numbers listed: 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Brand
Nidek
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial numbers listed: 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

✎ GovInfoNow

Questions people ask

Is this recall dangerous for patients?

No, the electromagnetic issue does not pose a direct risk to patients or users.

What should I do if I have the recalled microscope?

Contact Nidek directly for instructions on how to proceed with the recall.

How can I check if my microscope is affected?

Check the serial number against the list: 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Take action

Contact Nidek

We’ve drafted a message you can send Nidek to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0771-2020 — Nidek Nidek

Hello,

I own a Nidek that is covered by recall Z-0771-2020 from Nidek.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0771-2020 (February 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0771-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Nidek, Inc. recalls NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image

Lower-risk recall