Events

Retiro De Equipo (Recall) de Device Recall Sony Medical Monitor LMD1951MD 19 inch

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sony Latin America.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70702
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1514-2015
  • Fecha de inicio del evento
    2015-03-05
  • Fecha de publicación del evento
    2015-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134520
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Camera, surgical and accessories - Product Code KQM
  • Causa
    Monitor has either not turned on or has lost image during clinical use.
  • Acción
    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
  • Modelo / Serial
    Serial number range: 3000038-3004884, 3100035-3100058, 3100065-3100145.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Sony Medical Monitor LMD-1951MD 19 inch
  • Manufacturer
    Sony Latin America

Manufacturer

Sony Latin America
  • Dirección del fabricante
    Sony Latin America, 5201 Blue Lagoon Dr, Miami FL 33126-2064
  • Empresa matriz del fabricante (2017)
    Sony Corp.
  • Source
    USFDA