Retiro De Equipo (Recall) de Gas/Water Feeding Valve – PTX-OF-B194 (Used with PENTAX GI Video Endoscopes - 90i/90K series and i10/K10 series )

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has been informed about a product issue involving the of-b194 gas/water feeding valve. the reported defect may prevent stoppage of the supply of co2 gas during an endoscopic procedure with the potential for serious hazard to the patient, including bowel perforation.
  • Acción
    Device Technologies is advising customers to stop use of the PTX-OF-B194 Gas/Water Feeding Valve. Device Technologies will arrange for the affected stock to be collected. New stock of PTX-OF-B194 will be available by the end of September 2013. In the interim, customers are asked to use the alternative OF-B188 valve provided.