Events

Retiro De Equipo (Recall) de Pentax

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 Pentax Medical Company.

¿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
    73985
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2279-2016
  • Fecha de inicio del evento
    2016-04-06
  • Fecha de publicación del evento
    2016-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145831
  • 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
    Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
  • Causa
    Pentax medical video processor epk-i5010 has been shipped with a reusable pentax medical water bottle assembly (os-h4) which has not been cleared for use with this devices in the united states.
  • Acción
    Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.com.

Device

Pentax
  • Modelo / Serial
    Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Ultrasound Gastroscope || Product Usage: || Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • Dirección del fabricante
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    USFDA