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U.S. Department of Health and Human Services

Class 2 Device Recall SPECULAR MICROSCOPE CEM530

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  Class 2 Device Recall SPECULAR MICROSCOPE CEM530 see related information
Date Initiated by Firm August 08, 2016
Date Posted September 01, 2016
Recall Status1 Terminated 3 on January 09, 2017
Recall Number Z-2711-2016
Recall Event ID 74900
510(K)Number K151706  
Product Classification Microscope, specular - Product Code NQE
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. 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.
Code Information Microscopes with serial numbers: 120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044,120045, 120046, 120047, 120048, 120049, 120050.                           
Recalling Firm/
Manufacturer		 Nidek Inc
47651 Westinghouse Dr
Fremont CA 94539-7474
For Additional Information Contact Preeti Gandhi Bhatia
510-353-7718
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software change control
Action The firm, Nidek, sent a Dear Doctor letters entitled "RECALL NOTIFICATION" dated August 15, 2016 to affected sites by Federal Express. The letter informs users of the issue and stated that Nidek field service representatives will visit to install updated software. If you have any questions, please call Customer Service at 1-800-722-0219; Monday-Friday 8am to 5pm PST or email: cem530update@noritsuservice.com.
Quantity in Commerce 29 affected devices
Distribution US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
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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