Retiro De Equipo (Recall) de Synergy Air Squared

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Alternating Pressure Air Flotation Mattress - Product Code FNM
  • Causa
    These devices have the potential to overheat.
  • Acción
    All end users (those who either purchased the device and any customer that has rented) were notified by an Urgent Field Safety Notice on/about 10/31/2008. The letter informed the customers of the safety risk and list steps they can take to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that were sold, the consignee of each device was notified by letter for the safety risk and what they can do to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that are rented, an internal notification was sent via e-mail 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.


  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. || Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.
  • Manufacturer


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