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.
Monitor fell from the mounting bracket used to support the monitor.
조치
The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664.
If you have any questions about this matter, please feel free to contact me via email at Debbie.norris@agfa.com or call me at 864-421-1754.
Worldwide distribution: USA and countries of Puerto Rico and Canada.
제품 설명
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm || Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.