Events

Retiro De Equipo (Recall) de CORPUS II

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 Permobil, Ab.

¿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
    78079
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0005-2018
  • Fecha de inicio del evento
    2017-09-01
  • Fecha de publicación del evento
    2017-10-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158627
  • 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
    Wheelchair, powered - Product Code ITI
  • Causa
    There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
  • Acción
    The firm initiated the recall by letter on 09/01/2017. The distributor/dealers were instructed as follows: LOG INTO CORRECTION WEB PORTAL Immediately log into www.permobilfsa.com. Log in with the following ID and Password. CEASE DISTRIBUTION OF EXISTING INVENTORY Please examine your inventory for the serial numbers assigned to you, cease distribution, and quarantine those chairs. IMMEDIATELY PERFORM INSPECTION If you have distributed these serial numbers to end users, you must immediately contact them to perform a visual inspection of the top plate assembly looking for obvious signs of cracking. If the top plate shows no signs of cracking the wheelchair may continue to be used in accordance with the owners manual until the correction is performed. If the top plate does show signs of cracking please inform the user that the chair cannot be used until the correction is performed. Next, log into the web portal to obtain further instructions and assistance. In these cases which are expected to be rare, we will assist with a temporary solution to keep the client mobile during the time between inspection and correction. PERFORMING THE CORRECTION You will be notified when repair kits are available and the process to follow to obtain the proper kit for the serial number you are correcting. The web portal will include a template letter to send to end users explaining the hazard and the need to cooperate with this correction effort. Correction instructions and related supporting materials will also be available. We are also providing the end user with a certificate for a free light kit towards the purchase of a new Permobil power chair. Please contact your Permobil sales representative if you have any questions regarding this correction.

Device

CORPUS II
  • Modelo / Serial
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
  • Descripción del producto
    Electric Wheelchairs: || a) C300 CORPUS II || b) C350 CORPUS II || c) C400 CORPUS II || d) C400 CORPUS II LR || e) C500 CORPUS II || f) C500 CORPUS II LR
  • Manufacturer
    Permobil, Ab

Manufacturer

Permobil, Ab
  • Dirección del fabricante
    Permobil, Ab, Arvaltsvagen 10, Box 120, Timra Sweden
  • Empresa matriz del fabricante (2017)
    Investor AB
  • Source
    USFDA