BEUDAMED
    FDA Enforcement Class II Terminated

    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures

    Recall: Z-1187-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1187-2016
    Event ID
    73438
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien Medical Products (Shanghai) Manufacturing L.L.C.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    March 17, 2016
    Termination Date
    June 21, 2017
    Address
    Building 10 789 Puxinglu, Pujiang, Minhang, Shanghaishi, N/A, China

    Description

    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures

    Reason

    Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna.

    Code Info

    Model Numbers: CA15L1, CA20L1 and CA30L1

    Distribution

    Worldwide Distribution - US Nationwide, VA/govt/military consignees.

    Quantity

    4,920 units