Events

Retiro De Equipo (Recall) de Device Recall Viasys Vela Adult/Pediatric Lung Ventilator

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 Viasys Respiratory Care, Inc.dba Bird Products.

¿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
    37318
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0638-2007
  • Fecha de inicio del evento
    2007-01-31
  • Fecha de publicación del evento
    2007-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50340
  • 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
    Ventilator - Product Code CBK
  • Causa
    The graphical user interface may become slow in its response and in some cases non-responsive. under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
  • Acción
    On January 31, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks

Device

Device Recall Viasys Vela Adult/Pediatric Lung Ventilator
  • Modelo / Serial
    Lot numbers: AGT03640 thru AGT06049
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
  • Descripción del producto
    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
  • Manufacturer
    Viasys Respiratory Care, Inc.dba Bird Products

Manufacturer

Viasys Respiratory Care, Inc.dba Bird Products
  • Dirección del fabricante
    Viasys Respiratory Care, Inc.dba Bird Products, 1100 Bird Center Dr, Palm Springs CA 92262-8000
  • Source
    USFDA