GE Healthcare, LLC recalls GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for…

Recall date

May 16, 2019

Source

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

Recall number

Z-2131-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon…

Why it was recalled

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

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 Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.