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GE Healthcare, LLC recalls Revolution CT
Recalled July 14, 2021 · FDA recall Z-2004-2021 · GE Healthcare
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. · FDA Class II
Units
197 (US = 40; OUS = 157)
Sold at
Worldwide distribution - US Nationwide
Description
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.
Product
Revolution CT
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →