Events

Retiro De Equipo (Recall) de Device Recall AortaScan AMI 9700

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
    56411
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0004-2011
  • Fecha de inicio del evento
    2010-08-23
  • Fecha de publicación del evento
    2010-10-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93548
  • 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, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Causa
    The aortascan ami 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
  • Acción
    Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to: " Add the enclosed addendum to their current Users Manual. " Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or cservice@verathon.com.

Device

Device Recall AortaScan AMI 9700
  • Modelo / Serial
    Serial numbers:   A7001001, A7001005, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001048, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001062, A7001065, A7001066, A7001067, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001093, A7001094, A7001095, A7001096, A7001097, A7001098, A7001099, A7001100, A7001101, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001133, A7001134, A7001135, A7001136, A7001138, and A7001139.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
  • Descripción del producto
    AortaScan AMI 9700 || The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
  • 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