BEUDAMED
    FDA Recall Terminated

    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: Z-2132-2019 · Initiated May 16, 2019

    Recall

    Recall Number
    Z-2132-2019
    Event Number
    83096
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    MUE
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 16, 2019
    Terminated
    December 16, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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

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

    Action

    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,

    Distribution

    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.

    Quantity

    16