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.
There is a potential safety issue associated with the use of ge centricity pacs-iw and pacs web diagnostic software when dragging-and-dropping images from the navigator causing flipping of the images that may impact patient safety.
조치
GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. Accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479.
For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.
Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the United Kingdom
제품 설명
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || Device that receives, stores and communicates medical images and data from various imaging sources.