GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.

GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.

The firm, GE Healthcare, sent an"Urgent Medical Device Correction" letter GEHC Ref#25465 dated October 23, 2015 to its Consignees. The letter described the Safety Issues, Safety Instructions, Product Correction, Affected Product Details and Contact Information. The consignees were instructed to follow the instructions in existing CT User Manual and the safety instructions listed in the letter. GE will be delivering an addendum to the User Manual that reiterates these mitigations. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.