FDA-Device2015-12-16Class II
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 Medical Systems, LLC
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Affected count
125 (US = 37; OUS = 88)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2016Don't want to check this manually?
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