GE Healthcare
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1. Released Rendered PDF File Page 2 of 3 DOC1768373 Rev 1 GE Healthcare URGENT MEDICAL DEVICE CORRECTION 9900 Innovation Drive Wauwatosa WI 53226 USA lt Date of Letter Deployment gt GEHC Ref 25465 To Hospital Administrators Risk Managers Managers of Radiology Cardiology Radiologists Cardiologists RE Revolution CT head image quality beam hardening artifact GE Healthcare has recently become aware of a potential issue with routine head scans on 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 Issues Safety Instructions Product Correction 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 You can continue to use your Revolution CT product For routine head scans GE Healthcare recommends that you position the patient head so that the orbital meatal line is parallel to the scan plane and that you use GE Protocols 21 1 or 21 2 Reference Protocol Guide 5567862 1EN Rev 2 To further reduce the appearance of beam hardening artifacts use 40mm collimation Introducing 40mm collimation for routine head scans will result in more table transitions so sites should determine if 40 80 120 or 160mm collimation for head imaging bes2. sured 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 Sincerel James W Dennison Jeff Hersh M D Vice President Devices Chief Medical Officer GE Healthcare GE Healthcare Page 2 of 2
3. t meets the needs of your radiology practice When performing head scans be sure to follow the CT User Manual for information on how to help minimize these types of artifacts during routine head scans The information and warnings can be found in your Revolution CT User Manual 5480385 1XX Rev 2 For potential artifacts during scanning e Safety Chapter Chapter 3 Section 14 1 For beam hardening issues for head scans e Scan Chapter Chapter 11 Section 4 5 4 2 e Pediatric and Small Patient Chapter Chapter 5 Section 3 5 5 e General Information Chapter Chapter 21 Section 6 1 To minimize the effects of beam hardening artifacts during routine head scans GE Healthcare recommends that in addition to the information in the existing CT User Manual the site also follow the additional recommendations listed in the safety instructions above GE Healthcare will be delivering an addendum to the User Manual that reiterates these mitigations Additional improvements to image quality are currently in development This software will be distributed and installed on your system at no cost to you Page 1 of 2 Released Rendered PDF File Page 3 of 3 DOC1768373 Rev 1 Affected Revolution CT Scanners software version 15MW03 12 Product Details Contact If you have any questions or concerns regarding this notification please contact GE Information Healthcare Service at 1 800 437 1171 or your local Service Representative Please be as
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