BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    Recall: Z-2083-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2083-2016
    Event ID
    74158
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.-Littleton
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    March 17, 2016
    Classification Date
    July 6, 2016
    Termination Date
    April 6, 2021
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    Medtronic Navigation O-arm 02 surgical x-ray imaging system

    Reason

    Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).

    Code Info

    model number BT-700-02000

    Distribution

    Nationwide Distribution

    Quantity

    US - 63