Events

Retiro De Equipo (Recall) de Device Recall Radrex i

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 Toshiba American 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
    77888
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3111-2017
  • Fecha de inicio del evento
    2017-03-23
  • 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=158136
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " system error (2063)" which required a reboot and loss of the image.
  • Acción
    Toshiba America Medical Systems Inc. planned action to bring defect into compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. If you have any questions, please feel free to contact your local Toshiba representative at (800) 421-1968.

Device

Device Recall Radrex i
  • Modelo / Serial
    Serial No. W8B1572022
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution
  • Descripción del producto
    Toshiba Medical Radrex - i Digital Radiography X-ray system || Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.
  • Manufacturer
    Toshiba American Medical Systems

Manufacturer

Toshiba American Medical Systems
  • Dirección del fabricante
    Toshiba American Medical Systems, 2441 Michelle Dr, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA