GE Healthcare, LLC recalls Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission To…

Recall date

February 12, 2019

Source

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

Recall number

Z-1749-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

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

What was recalled

Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.