BEUDAMED
    FDA Enforcement Class II Terminated

    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.

    Recall: Z-2771-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2771-2015
    Event ID
    71657
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sony Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    September 16, 2015
    Termination Date
    April 26, 2017
    Address
    1 Sony Dr, Park Ridge, NJ, 07656-8002, United States

    Description

    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.

    Reason

    Tthe medical monitor has either not turned on or has lost image during clinical use.

    Code Info

    Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145 Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157

    Distribution

    Worldwide Distribution - US Distribution to the states of : AZ, CA, NC, PA, IA, OH and FL., and to the countries of : China, Japan, Taiwan, South Korea and Indonesia.

    Quantity

    4952 units (1016 US; 3936 OUS)