Z-0771-2020Class III

NIDEK Specular Microscope, Model CEM-530 -

Name: Z-0771-2020 NIDEK Specular Microscope, Model CEM-530 -
Creator: Nidek, Inc.
Published: 2019-02-25
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2019-02-25 / Terminated / root cause: design

FDA source

Nidek, Inc. began a recall of NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation... on 2019-02-25. FDA classified it as Class III and gives the reason as "The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0771-2020
Classification: Class III
Status: Terminated
Initiated: 2019-02-25
Posted: 2020-01-02
Terminated: 2021-06-15
Recalling firm: Nidek Incorporated
Product: NIDEK Specular Microscope, Model CEM-530 - Product Usage: The 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.
Product code: NQE Microscope, Specular
Reason for recall: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 2/7/2019 via FedEx explaining the issue, informing the consignee there was no risk associated with use of the device, and that the firm is preparing for the replacement parts in order to schedule for the correction to be made.
Quantity in commerce: 13 devices
Distribution: US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.
Product codes and lots: Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0771-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-08	2020-01-02

Product code NQE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)