Events

Retiro De Equipo (Recall) de Invacare AC-Powered Adjustable Hospital Bed.

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 Invacare Corporation.

¿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
    56333
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2393-2010
  • Fecha de inicio del evento
    2006-10-16
  • Fecha de publicación del evento
    2010-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93259
  • 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, Ac-Powered Adjustable Hospital - Product Code FNL
  • Causa
    Invacare corporation, florida issued a device correction in october 2006 for the ivc bed foot actuator used on the ivc bed series, models 5890 ivc and 5490 ivc. the actuators were not in the fully extended position and could not be mounted onto the beds. all affected consignees were notified of this correction in october 2006.
  • Acción
    Invacare Corporation issued a notice of an Urgent Field Correction to Consignees on 10/18/2006. Consignees were instructed to check the serial number of their units to see if they were potentially affected. If so, the firm provided inspection and adjustment instructions of the foot actuator to prevent a likelihood of injury. After adjustment, the consignees were requested to complete and return the enclosed tracking sheet acknowledging receipt of the recall notice and correction of the bed(s). For questions or assistance regarding this correction, please contact the Customer Relationship Management Group at (800) 333-6900, or via e-mail at CRMGroup@Invacare.com.

Device

Invacare AC-Powered Adjustable Hospital Bed.
  • Modelo / Serial
    Models: 5890 and 5490
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed throughout the U.S.
  • Descripción del producto
    Invacare AC-Powered Adjustable Hospital Bed. || Model 5890 IVC and 5490 IVC. || Manufactured by: || Invacare Corp. 2101 East Lake Mary Blvd., Sanford, FL 32773.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Dirección del fabricante
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Empresa matriz del fabricante (2017)
    Invacare Corporation
  • Source
    USFDA