U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Laser, ophthalmic - Product Code HQF
원인
Retrospective review found that a engineering change order initiated in may 2013 for a memory function problem was not reported as required.
조치
Nidek Engineers visited all affected sites to install new software version.
For questions regarding this recall call 510-353-7785.
MC-500 Multicolor Laser Photocoagulator using software version 2.20. || Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.