FDA-Device2019-08-07Class II
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.
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
82
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2019Don't want to check this manually?
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