FDA-Device2021-07-14Class II
Revolution CT
GE Healthcare, LLC
Hazard
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
Sold states
Worldwide distribution - US Nationwide
Affected count
197 (US = 40; OUS = 157)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Revolution CT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2004-2021Don't want to check this manually?
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