BEUDAMED
    FDA Recall 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 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-2771-2015
    Event Number
    71657
    Firm
    Sony Medical Systems
    FEI Number
    2246606
    Product Code
    FWB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 13, 2015
    Posted
    September 16, 2015
    Terminated
    April 26, 2017
    Address
    1 Sony Dr, Park Ridge, NJ, 07656-8002

    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.

    Action

    Sony Corporation sent an URGENT: MEDICAL DEVICE FIELD ACTION field letter dated January 13, 2015. Customers are asked to affix the warning sticker to the rear of the monitor and place the adhesive seal over the AC inlet. If the firm does not possess an AC adaptor (AC-110MD) for each of the affected monitors, stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit the appropriate failure mode. Questions can be directed to 866-789-SONY (7669) between 8:00 am and 8:00 pm Monday through Friday.

    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)