Events

Retiro De Equipo (Recall) de Device Recall Accu2i pMTA Applicator

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 Angiodynamics, 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
    77631
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0526-2018
  • Fecha de inicio del evento
    2017-06-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156961
  • 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, ablation, microwave and accessories - Product Code NEY
  • Causa
    The firm is recalling product that has the potential to not function during use. the product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code high reflective power displayed on the microwave generator.
  • Acción
    URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken.

Device

Device Recall Accu2i pMTA Applicator
  • Modelo / Serial
    Lots: 15310411, 15320416, 15340428, 15350430, 15360434, 15380439, 15400449, 15420453, 15430454, 15440459, 15460466, 15470468, 15490476, 15500480, 15520487, 16010488, 16050494, 16070499, 16080502, 16100508, 16120512, 16140517, 16150520, 16170528, 16180530, 16190535, 16210540, 16230549, 16240550, 16250556, 16260561, 16270562, 16300568, 16310572, 16320573, 16350581, 16370590, 16380592, 16390595, 16400599, 16410603, 16420604, 16440611, 16450617, 17010645, 17020649, 17030653, 17040657, 17060662, 17070666, 17090673, 17100675, 17130686*, 17130687.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US Nationwide
  • Descripción del producto
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Dirección del fabricante
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA