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Recall Observatory FDA recall evidence

Device 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.

Z-2132-2019

May 16, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 83096
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-2132-2019

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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