FDA-Device2019-08-07Class II
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.
GE Healthcare, LLC
Hazard
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Sold states
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, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
Affected count
16
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2132-2019Don't want to check this manually?
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