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
Radionuclide Radiation Therapy System - Product Code IWB
원인
Need to modify the closing speed of the shielding doors in the event of an emergency exit.
조치
A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
제품 설명
Leksell Gamma Knife Perfexion, Article #715000. || Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.