Events

Retiro De Equipo (Recall) de PENTAX Endoscopic Accessories

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
    66379
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0084-2014
  • Fecha de inicio del evento
    2013-09-16
  • Fecha de publicación del evento
    2013-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122221
  • 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
    Insufflator, automatic carbon-dioxide for endoscope - Product Code FCX
  • Causa
    Pentax medical has become aware of a product issue associated with the of-b194 gas/water feeding valve. a manufacturing defect may cause improper stoppage of co2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
  • Acción
    PENTAX Medical sent an "Urgent Device Recall" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. . The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall. The customer was instructed to identify and notify their customers if they further distributed the product. The notification instructs users to return the OF-B194 Valves for replacement with corrected product. Customers were asked to complete the attached response form and fax back to Pentax Medical at 1.201.799.4063. An enclosed UPS Airway Bill is to be used to return recalled product. A contact phone number and email address is provided if the customer has questions (1.800.431.5880 xt2064). For questions regarding this recall call 800-431-5880. Pentax issued a press release on 10/31/2013. Pentax posted their press release on their website at www.pentax.com.

Device

PENTAX Endoscopic Accessories
  • Modelo / Serial
    Model OF-B194
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
  • Descripción del producto
    PENTAX Endoscopic Accessories. OF-B194. Made in Japan. || PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
  • 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