GE Healthcare, LLC recalls GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide…

Recall date

May 16, 2019

Source

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

Recall number

Z-2132-2019

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 Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.