Events

Retiro De Equipo (Recall) de Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems

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 Acist Medical Systems.

¿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
    50501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0643-2009
  • Fecha de inicio del evento
    2008-11-10
  • Fecha de publicación del evento
    2009-01-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75534
  • 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
    Angiographic Injector and Syringe - Product Code DXT
  • Causa
    Multiple injections may result. it has been determined that when using the acist cvi angiographic injection system to synchronize with the toshiba infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.
  • Acción
    ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.

Device

Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems
  • Modelo / Serial
    Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.
  • Descripción del producto
    ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. || Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Dirección del fabricante
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344
  • Empresa matriz del fabricante (2017)
    Bracco Spa
  • Source
    USFDA