Events

Retiro De Equipo (Recall) de Device Recall EPShuttle/Stockert J50/Stockert J70

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
    59331
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3178-2011
  • Fecha de inicio del evento
    2011-07-07
  • Fecha de publicación del evento
    2011-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102297
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Causa
    Biosense webster has initiated a voluntary field notification to all customers that have a stockert 70 radio frequency generator, to communicate undetected software anomalies in the form of software release note in order to amend the labeling and thereby enhance the safety of the product.
  • Acción
    The recall communication was initiated on 7/8/11 and 7/11/11 with Biosense Webster forwarding A Customer Notification Letter, Acknowledgement Form and Software Release Note (Attachments 3, 4 and 1) via FedEx to all U.S. customers who purchased the Stockert 70 Radio Frequency Generator. Two letters and forms were sent to U.S. customers via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. The Release Note provides tips for the avoidance of potential events when working with the EP-SH UTTLE, STOCKERT 70, STOCKERT J50 or STOCKERT J70 RF generators with SW versions 1.035 / 1.035J /1.035J70 to 1.037/1.037J70.

Device

Device Recall EPShuttle/Stockert J50/Stockert J70
  • Modelo / Serial
    Software version: 1.035J
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
  • Descripción del producto
    STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 || Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequency energy during cardiac ablation procedures. || Stockert 70 in foreign countries is also known as: EP-Shuttle/Stockert J50/Stockert J70 || With software versions: 1.035/1.035J/1.035J70 to 1.037/1.037J70
  • 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