Date Initiated by Firm |
May 24, 2013 |
Date Posted |
November 17, 2014 |
Recall Status1 |
Terminated 3 on November 17, 2014 |
Recall Number |
Z-0222-2015 |
Recall Event ID |
69531 |
510(K)Number |
K110228
|
Product Classification |
Laser, ophthalmic - Product Code HQF
|
Product |
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. |
Code Information |
MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609 |
Recalling Firm/ Manufacturer |
Nidek Inc 47651 Westinghouse Dr Fremont CA 94539-7474
|
For Additional Information Contact |
Neo Yamaguchi 510-353-7785
|
Manufacturer Reason for Recall |
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
|
FDA Determined Cause 2 |
Software design |
Action |
Nidek Engineers visited all affected sites to install new software version.
For questions regarding this recall call 510-353-7785. |
Quantity in Commerce |
5 |
Distribution |
US Distribution in the states of: CA, NE, and NY. |
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 = HQF and Original Applicant = NIDEK INCORPORATED
|