Events

Retiro De Equipo (Recall) de Device Recall Triumph CT and Triumph II CT scanners

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 Northridge Tri-Modality Imaging,.

¿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
    74838
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2833-2016
  • Fecha de inicio del evento
    2016-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148565
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    The firm has determined that several triumph/triumph ii research ct scanners produced by northridge trimodality imaging, inc dba trifoillmaging (or by gamma medica-ideas, inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 cfr 1020.40 (cabinet x-ray standards).
  • Acción
    TriFoil lmaging planned action to bring defect into Compliance: 1. All repairs were performed at customer facilities. Customers were contacted by phone to arrange a convenient repair time. 2. TriFoil service engineers installed a collimator on each of the affected cabinet x-ray systems to bring their emission rates into compliance with the emission limit in the performance standard. 3. Full radiation surveys were performed, at maximum exposure settings, to verify each repair was effective. 4. All costs associated with the repair and follow-up testing were paid directly by TriFoil Imaging. CDRH approves the CAP and understands that the CAP was completed on August 29, 2016. For further questions please call (818) 709-2468.

Device

Device Recall Triumph CT and Triumph II CT scanners
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Distribution
  • Descripción del producto
    TriFoillmaging Triumph/Triumph II Research CT scanners.
  • Manufacturer
    Northridge Tri-Modality Imaging,

Manufacturer

Northridge Tri-Modality Imaging,
  • Dirección del fabricante
    Northridge Tri-Modality Imaging,, 9457 de Soto Ave, Chatsworth CA 91311-4920
  • Empresa matriz del fabricante (2017)
    Trudell Medical Limited
  • Source
    USFDA