GE Healthcare, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6
Products Sold
Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6
GE Healthcare, LLC is recalling GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina due to Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Recommended Action
Per FDA guidance
On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026