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