BEUDAMED
    FDA Recall Terminated

    Sony Medical Monitor LMD-1951MD 19 inch

    Recall: Z-1514-2015 · Initiated March 5, 2015

    Recall

    Recall Number
    Z-1514-2015
    Event Number
    70702
    Firm
    Sony Latin America
    FEI Number
    3010052497
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2015
    Posted
    April 23, 2015
    Terminated
    December 14, 2016
    Address
    5201 Blue Lagoon Dr, Miami, FL, 33126-2064

    Description

    Sony Medical Monitor LMD-1951MD 19 inch

    Reason

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

    Action

    SOLA sent an URGENT MEDICAL DEVICE FIELD ACTION dated March 2, 2015, to all affected customers. Within that notification SOLA requests that you send the customer letter included in Attachment 1 of this notification to all customers who have purchased the affected monitors from you. The letter instructs customers who already possess an AC adapter for each of their affected monitors to only use the AC adaptor when the monitors are in use. If you have units in inventory that can be provided with an AC adapter, we will provide under separate cover kits that contain: 1) a sticker warning and 2) an adhesive seal to go over the AC outlet and 3) correction instructions document. If you have units in inventory that cannot be accompanied by an AC adapter, for each of these affected monitors, do not ship the unit until the permanent corrective action described below has been applied. Please complete the MEDICAL DEVICE RECALL RETURN RESPONSE included in Attachment 2 to the contact person identified on the form. Please contact me below if you have any questions. 305-260-4000 Hours of operation: 8am to 8pm (Monday through Friday, excluding holidays).

    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