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
Full-montage standard electroencephalograph - Product Code GWQ
원인
The following implied or stated indications in stellate labeling with harmoniae software have not yet been cleared by the food and drug administration (fda) for sale in the united states of america.
조치
Stellate Systems sent a "DEVICE CORRECTION" letter dated April 6, 2009 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The firm provided information on how to verify if customers had the affected product. Software updates will be available to all customers in possession of the affected product. Customers were instructed to call the Customer Support line at 1-888-742-1306 with any questions or concerns they may have regarding the notification.
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Denmark, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Norway, Rep. DE Panama, Spain, Switzerland, Taiwan ROC, and Turkey.
제품 설명
Harmonie software in use with: || Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) || Harmonie-S Sleep System (Model HSYS-REC-DUO) || VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) || Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). || Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations.