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GE Healthcare, LLC recalls GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide
Recalled August 7, 2019 · FDA recall Z-2132-2019 · GE Healthcare
Hazard
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. · FDA Class II
Units
16
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 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.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →