Events

Retiro De Equipo (Recall) de Device Recall superDimension Bronchus System

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 SuperDimension, 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
    36947
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0666-2007
  • Fecha de inicio del evento
    2006-11-29
  • Fecha de publicación del evento
    2007-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49649
  • 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
    endoscopic loacalization system - Product Code JAK
  • Causa
    The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superdimension bronchus system was used. the biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
  • Acción
    An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.

Device

Device Recall superDimension Bronchus System
  • Modelo / Serial
    superDimension Bronchus System with the following serial numbers: S0030019, S030051, S030052, S030054, S030055, S030058 thru S030062, S030067, S030068, S030077 thru S030081; S030084, S030085, S030088 thru S030095; S030097 thru S030100, S030103, S030104, S030105, S030390, S030447, S030449, S0030009, S0030011, S0030013, S0030014, S0030015, S0030021, S0030022, S0030026, S0030042, S030043 thru S030050, S030053, S030056, S030057, S030063, S030064, S030066, S030069 thru S030076, S030082, S030086, S030087, S030096, S030102, S030477.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
  • Manufacturer
    SuperDimension, Inc.

Manufacturer

SuperDimension, Inc.
  • Dirección del fabricante
    SuperDimension, Inc., 161 Cheshire Lane North, Suite 100, Minneapolis MN 55441
  • Source
    USFDA