GE Healthcare, LLC recalls GE Pristina Serena - Product Usage: Pristina Serena is an op
Recalled 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.
Hazard / Issue
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6
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