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U.S. Department of Health and Human Services

Class 3 Device Recall NIDEK Specular Microscope

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  Class 3 Device Recall NIDEK Specular Microscope see related information
Date Initiated by Firm February 25, 2019
Create Date January 02, 2020
Recall Status1 Terminated 3 on June 15, 2021
Recall Number Z-0771-2020
Recall Event ID 84112
510(K)Number K130565  K151706  K173980  
Product Classification Microscope, specular - Product Code NQE
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.
Code Information Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.
Recalling Firm/
Manufacturer		 Nidek, Inc.
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Mr. Todd Milholland
800-223-9044
Manufacturer Reason
for Recall		 The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQE and Original Applicant = NIDEK CO., LTD.
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