GE Healthcare URGENT Field Safety Notice <Date of Letter Deployment> 9900 Innovation Drive Wauwatosa, WI 53226 USA GEHC Ref#25457 To: Hospital Administrators / Risk Managers Managers of Radiology/Cardiology Radiologists/Cardiologists RE: Torque check not performed on the Revolution CT scanner GE Healthcare has recently become aware of a potential safety issue due to a required torque check on three bolted joints of your Revolution CT scanner. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety Issue GE Healthcare has become aware that a required torque check was not performed on three joints on your Revolution system during the manufacturing process. GE Healthcare does have evidence that the CT systems were originally torqued during the manufacturing process. There is a requirement to check the torque a second time during the manufacturing process, but it was not completed at the time of manufacturing. In the unlikely event that a component becomes loose on the CT gantry during operation, it could result in significant bodily injury if it were expelled as a highenergy outward radial projectile. Safety Instructions The site can continue to use the GE Healthcare Revolution CT scanner. If the joint loosens, the system would fail its balance test during the daily FastCal, and the system will display an error message. Should this occur, stop using the system and call your service team to bring the system back into proper operation. Affected Product Details Revolution CT Computed Tomography X-ray systems with software version 14MW14.29 distributed from July 2014 to November 2014. The software version is visible on the homepage of the service desktop. Product Correction GE Healthcare will arrange a site visit to complete the torque check on your system by rechecking the torque on the joints that were missed during the manufacturing process. A GE Healthcare service representative will contact you to arrange for this correction. This activity will be performed at no cost to you. Contact Information Call Center phone numbers: xxxxxxx For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above. Sincerely, James Dennison Vice President QARA GE Healthcare Systems Werner Van den Eynde, M.D. Acting Chief Medical Officer GE Healthcare Page 1 of 1