Events

Retiro De Equipo (Recall) de Kalare (DREXKL80)

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 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
    78166
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0012-2018
  • Fecha de inicio del evento
    2017-09-12
  • 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=158813
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Causa
    During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.
  • Acción
    Toshiba 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. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. Thank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. For further questions please call (714) 730-5000.

Device

Kalare (DREXKL80)
  • Modelo / Serial
    Model: HDR-08A
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution
  • Descripción del producto
    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) || Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, PO Box 2068, 2441 Michelle Dr, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA