Events

Retiro De Equipo (Recall) de Device Recall Envision E700 Low Airloss Therapy Surface

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 Hill-Rom Manufacturing, 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
    49490
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0088-2009
  • Fecha de inicio del evento
    2008-06-19
  • Fecha de publicación del evento
    2008-10-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73614
  • 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
    Powered Flotation Therapy Bed - Product Code IOQ
  • Causa
    A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.
  • Acción
    An internal Modification Notice dated 9/1/08 was sent via email to Service Centers (because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the consignee). Each Service Center will perform the correction on the units affected. Each device in the affected serial number range will be tested for the software defect. If the defect is found, the circuit board that contains the defective software will be replaced. The Field Action Plan is expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 months from July, 2008.

Device

Device Recall Envision E700 Low Airloss Therapy Surface
  • Modelo / Serial
    Serial numbers DB100527 thru DB101305.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and country of Canada.
  • Descripción del producto
    Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. || The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Dirección del fabricante
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA