GE Healthcare, LLC recalls GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applicatio…

Recall date

May 9, 2016

Source

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

Recall number

Z-1915-2016

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuw…

Why it was recalled

GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie

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 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.