Events

Retiro De Equipo (Recall) de Device Recall ACIST

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
    64840
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1145-2013
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2013-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117164
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Causa
    Acist medical systems is issuing a voluntary recall notice for three specific lots of bt2000 automated manifold kits. for these specific lots, acist has received field reports related to ingress of air into the manifold body. this has been detected by the air column detect sensor halting the injection, and normally replacement of the bt2000 automated manifold kit is necessary in order to proceed w.
  • Acción
    ACIST Medical Systems sent an Urgent Medical Device Recall letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to discontinue use or further distribution of the product. If you possess inventory containing any of the lot numbers listed above, please discontinue use or further distribution of these products. Please return this inventory to ACIST. Upon receipt of the returned BT2000 Automated Manifold Kits, ACIST will arrange for a shipment of replacement kits at no charge. To order additional or immediate replacement product, please contact BRACCO customer service at 1-877-BRACCO9 (1-877-272-2269), option 1. Please also complete and return the enclosed Medical Device Recall Form (see enclosure). Even if you do not possess any of the affected product in your inventory, the form needs to be completed and returned, indicating that you have no remaining units containing these lot numbers in your inventory.

Device

Device Recall ACIST
  • Modelo / Serial
    23884007, 23884008, 23884009
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
  • Descripción del producto
    ACIST Medical Systems Inc. || The ACIST Angiographic Injection System is 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 55344-2137
  • Empresa matriz del fabricante (2017)
    Bracco Spa
  • Source
    USFDA