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.
After opening and closing a study on a central monitoring system while a study is still open on an in-room nx system, a problem of image mix-up can occur on the in-room nx system.
조치
An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.
Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
제품 설명
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 || Agfa's Computed Radiography Systems with NX Workstations are intended for use in || providing diagnostic quality images to aid the physician with diagnosis.