Z-2132-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- May 16, 2019
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
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.
Reason for Recall
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
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.
Code Information
Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6