Events

Retiro De Equipo (Recall) de Device Recall Verathon BladderScan BVI 9400

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 Verathon, 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
    52769
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1939-2009
  • Fecha de inicio del evento
    2009-05-18
  • Fecha de publicación del evento
    2009-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83963
  • 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
    Ultrasonic pulsed echo imaging system - Product Code IYO
  • Causa
    Three specific issues are being addressed: 1. calculation and use of an incorrect year in dates after 12/31/2009. 2. double scans, continuous scans, and double printing. 3. calibration sensitivity.
  • Acción
    U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading. Canadian customers were phoned by Verathon. For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia. Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.

Device

Device Recall Verathon BladderScan BVI 9400
  • Modelo / Serial
    Units with serial numbers ranging from 1000 to 3179 are affected. (Serial number 1564 was not used.) The serial number is assigned as a sequential number, with no breakdown.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
  • Descripción del producto
    The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Dirección del fabricante
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA