Events

Retiro De Equipo (Recall) de Device Recall Magellan Robotic Catheter System Accessory Kits

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 Hansen Medical 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
    73677
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1564-2016
  • Fecha de inicio del evento
    2016-03-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144725
  • 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
    System, catheter control, steerable - Product Code DXX
  • Causa
    Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kgy.
  • Acción
    Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581.

Device

Device Recall Magellan Robotic Catheter System Accessory Kits
  • Modelo / Serial
    Lot number 20151117
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to OH, TX. FL, CA and GA.
  • Descripción del producto
    Magellan Robotic Catheter Accessory Kits, || Model number MACC 50 and MACC80. || Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
  • Manufacturer
    Hansen Medical Inc

Manufacturer

Hansen Medical Inc
  • Dirección del fabricante
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • Empresa matriz del fabricante (2017)
    Auris Health, Inc.
  • Source
    USFDA