Events

Retiro De Equipo (Recall) de Device Recall Clinitron At Home Air Fluidized Therapy Unit

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
    27190
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0057-04
  • Fecha de inicio del evento
    2002-01-14
  • Fecha de publicación del evento
    2003-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29401
  • 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
    Bed, Air Fluidized - Product Code INX
  • Causa
    Power cord overheating.
  • Acción
    Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.

Device

Device Recall Clinitron At Home Air Fluidized Therapy Unit
  • Modelo / Serial
    Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Hill Rom primarily leases these units to home care patients and some are sold nationwide.
  • Descripción del producto
    Clinitron At Home¿ Air Fluidized Therapy Unit
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

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