BEUDAMED
    FDA Recall Terminated

    Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R

    Recall: Z-0404-2019 · Initiated September 17, 2018

    Recall

    Recall Number
    Z-0404-2019
    Event Number
    81355
    Firm
    Medtronic Navigation, Inc.-Littleton
    FEI Number
    3004785967
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 17, 2018
    Terminated
    May 28, 2020
    Address
    300 Foster St, Littleton, MA, 01460-2017

    Description

    Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R

    Reason

    O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit

    Action

    Medtronic Navigation issued Urgent Medical Device Correction letter on 9/27/18, notification letter advising, Medtronic field service personnel will install 4.1.0 software onto the designated consignee systems, update IFU and product labels as well as install a new designed AC power input circuit within the Mobile View Station {MVS). Questions regarding contact Medtronic Technical Support at 1-800-595-9709.

    Distribution

    Worldwide Distribution - US Nationwide Foreign: AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CANADA CHILE COLOMBIA DENMARK FINLAND FRANCE GERMANY HR ICELAND INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KOREA, REPUBLIC OF LUXEMBOURG MARTINIQUE MEXICO NETHERLANDS NEW ZEALAND POLAND PORTUGAL PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED ARAB EMIRATES UNITED KINGDOM

    Quantity

    641 units