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GE Healthcare, LLC recalls GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for s
Recalled August 7, 2019 · FDA recall Z-2131-2019 · GE Healthcare
Hazard
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. · FDA Class II
Units
82
Sold at
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.
Description
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Product
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.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →