Events

Recall of Device Recall Sony Medical Monitor LMD1951MD 19 inch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sony Latin America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70702
  • Event Risk Class
    Class 2
  • Event Number
    Z-1514-2015
  • Event Initiated Date
    2015-03-05
  • Event Date Posted
    2015-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134520
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Camera, surgical and accessories - Product Code KQM
  • 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).

Device

Device Recall Sony Medical Monitor LMD1951MD 19 inch
  • Model / Serial
    Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Sony Medical Monitor LMD-1951MD 19 inch
  • Manufacturer
    Sony Latin America

Manufacturer

Sony Latin America
  • Manufacturer Address
    Sony Latin America, 5201 Blue Lagoon Dr, Miami FL 33126-2064
  • Manufacturer Parent Company (2017)
    Sony Corp.
  • Source
    USFDA