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
Accelerator, linear, medical - Product Code IYE
원인
If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. if cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.
조치
ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
For questions regarding this recall call 770-670-2548
Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico
제품 설명
Elekta Synergy XVI 4.5 and R4.6 || To be used as part of radiation therapy treatment process.