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
Potential for positional errors following automatic table movement (atm).
조치
Customers were notified via letter on about [DATE]. Instructions include to post the notice in a place accessible to all users until the action is closed and to advise appropriate personnel working with the affected product of the recall action. Additionally Elekta plans to release Integrity R4.0.0, which should identify positional errors over 5 mm, in the first half of 2018.