GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-2132-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 16, 2019

Date Posted: August 7, 2019

Recall Number: Z-2132-2019

Event ID: 83096

Reason for Recall:

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

Status: Terminated

Product Quantity: 16

Code Information:

Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated