Events

Retiro De Equipo (Recall) de Device Recall 10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue

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 Biosense Webster, 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
    58104
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1839-2011
  • Fecha de inicio del evento
    2011-02-15
  • Fecha de publicación del evento
    2011-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98354
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Causa
    The recall was initiated because biosense webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-ifu) for the "10 ft. interface cable, 10 pin-shielded tip pins to 12 pin-blue", catalog number d128709, through the j&j; gateway (ie, e-ifu website).
  • Acción
    Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated March 16, 2011, to all affected customers (via express mail). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed Acknowledgement Form to confirm that all customers who received the product have been notified accordingly of this concern. If customers have any questions or require additional information, they are to contact their BWI representative and return the Acknowledgement form to: Biosense Webster, Inc. l5715 Arrow Highway Irwindale, CA 91706 Attn: Recall Coordinator - Virgil Ellsworth Phone: (909) 839-8500 Fax Number: (909) 839-7207. For questions regarding this recall call 909-839-7207.

Device

Device Recall 10 ft. Interface Cable, 10 Pin Shielded Tip Pins to 12 Pin Blue
  • Modelo / Serial
    Catalog Number D128709
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - including GA, KY, NV, WA, PA, and UT
  • Descripción del producto
    10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. || This cable is used to connect an Auto 10 10-pole catheter to an EP recording system.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Dirección del fabricante
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA