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
Monitor, patient position, light-beam - Product Code IWE
원인
The alignment lasers are missing the labels required by radiation safety regulations.
조치
GE Planned action(s) to repair defect or to bring product into compliance:
The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 5 units consists of the following:
1. New labels will be mailed to all purchasers, with instructions to apply the label in the appropriate location on the unit, or a GE field engineer will be sent to each user site to complete the correction.
2. All mailings and service calls will be made at no cost to the purchaser.
3. The corrections will be completed by August 1, 2015.
If you have any questions, please contact your local Service Representative or call 1 (800) 437-1171.