Events

Retiro De Equipo (Recall) de Omron 3Way Instant Thermometer

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 Omron Healthcare, Inc..

¿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
    33801
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0466-06
  • Fecha de inicio del evento
    2005-10-25
  • Fecha de publicación del evento
    2006-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42461
  • 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
    Thermometer, Electronic, Clinical - Product Code FLL
  • Causa
    Omron is recalling the omron 3-way instant thermometers due to possible overheating of the probe tip.
  • Acción
    Omron sent recall letters dated 10/21/05 to all of their direct accounts, informing them that the probe tip could overheat and possibly burn the person whose temperature is being taken. The accounts were instructed to check the lot number on their thermometers immediately to see if they fall within the range of affected thermometers (lots beginning with 01-32, 01-36, 01-37 and 01-38). The accounts were instructed to call Omron at 1-800-634-4350 if their unit is affected to get instructions on how to return the unit to Omron for a refund. Omron issued a press release on 10/24/05 to alert consumers who may have purchased the thermometer at a retail pharmacy, and has posted both the press release and the recall letter on their website at www.omronhealthcare.com.

Device

Omron 3Way Instant Thermometer
  • Modelo / Serial
    Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and internationally to Canada, Chile, Venezuela and Singapore
  • Descripción del producto
    Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061, Made in Philippines; UPC 73796-43600
  • Manufacturer
    Omron Healthcare, Inc.

Manufacturer

Omron Healthcare, Inc.
  • Dirección del fabricante
    Omron Healthcare, Inc., 1200 Lakeside Dr, Bannockburn IL 60015-1243
  • Source
    USFDA