| Class 2 Device Recall MC500 Multicolor Laser Photocoagulator | |
Date Initiated by Firm | March 27, 2012 |
Date Posted | February 19, 2015 |
Recall Status1 |
Terminated 3 on February 19, 2015 |
Recall Number | Z-1127-2015 |
Recall Event ID |
70335 |
510(K)Number | K110228 |
Product Classification |
Laser, ophthalmic - Product Code HQF
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Product | MC-500 Multicolor Laser Photocoagulator;
Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. |
Code Information |
Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076 |
Recalling Firm/ Manufacturer |
Nidek Inc 47651 Westinghouse Dr Fremont CA 94539-7474
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For Additional Information Contact | Neo Yamaguchi 510-353-7785 |
Manufacturer Reason for Recall | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. |
FDA Determined Cause 2 | Component design/selection |
Action | Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction. |
Quantity in Commerce | 16 units in commerce |
Distribution | Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HQF
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