GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.

GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.

GE provided Urgent Medical Device Correction letters to consignees in the following countries: Canada, Finland, France, Germany, Guadeloupe, Italy, Japan, Latvia, Martinique, Netherlands, Norway, Poland, Reunion, Romania, Saudi Arabia, Singapore, Spain,Sweden, Switzerland, Turkey and the United Kingdom. The letters were dated March 27, 2012 and were addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US 800-437-1171, Japan 0120-055-919 and for other countries contact your local GE Healthcare Service Representative). *Letters to other consignees is being planned for September 2013.