BEUDAMED
    FDA Enforcement Class II Terminated

    Sony Medical Monitor LMD-1951MD 19 inch

    Recall: Z-1514-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1514-2015
    Event ID
    70702
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sony Latin America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 29, 2015
    Initiation Date
    March 5, 2015
    Classification Date
    April 23, 2015
    Termination Date
    December 14, 2016
    Address
    5201 Blue Lagoon Dr, Miami, FL, 33126-2064, United States

    Description

    Sony Medical Monitor LMD-1951MD 19 inch

    Reason

    Monitor has either not turned on or has lost image during clinical use.

    Code Info

    Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.

    Distribution

    Worldwide Distribution - US Distribution to the states of : FL and NC., and to the countries of : Ecuador, Costa Rica, Brazil, Nicaragua, Venezuela, Peru, Colombia, Dominican Republic, and South Korea.

    Quantity

    4,764 units