Events

Retiro De Equipo (Recall) de Belos VR

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 Biotronik 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
    27417
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0074-04
  • Fecha de publicación del evento
    2003-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-02-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29846
  • 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
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Causa
    Potential extended charge time anomalies.
  • Acción
    Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients.

Device

Belos VR
  • Modelo / Serial
    Serial Numbers: 78112903, 78112904, 78112905, 78112906, 78112907, 78112908, 78112909, 78113004, 78113012, 78113013, 78113014, 78113015, 78113016, 78113017, 78113018, 78113019, 78113020, 78113022, 78113054, 78113055, 78113057, 78113058, 78113059, 78113060, 78113061, 78113062, 78113063, 78113064, 78113066, 78113067, 78113071, 78113082, 78113084, 78113085, 78113086, 78113090, 78113091, 78113092, 78113093, 78113094, 78113095, 78113096, 78113113, 78113114, 78113115, 78113116, 78113117, 78113118, 78113119, 78113120, 78113121, 78113122, 78113123, 78113124.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    The firm distributes to physicians located throughout the US.
  • Descripción del producto
    Belos VR Implantable Cardioverter Defibrillator
  • Manufacturer
    Biotronik Inc

Manufacturer

Biotronik Inc
  • Dirección del fabricante
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA