GE Medical Systems, LLC recalls GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular…

Recall date

October 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0401-2016

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.