Events

Retiro De Equipo (Recall) de VP 1600 HD STILL CAPTURE SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CONMED CANADA.

¿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
    89971
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-03-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Through the conmed linvatec complaint system conmed linvatec has received sporadic complaints where the vp1600 still capture console software may give the appearance of being fully locked up but is actually unresponsive with certain keyboard inputs. the vp1600 is still fully functional and presents a full motion image on the main display monitor but may not be able to capture a still image frame (picture) for record storage purposes using the keyboard. the user can still capture a still image using the camera head unit. the user may also feel compelled to turn off and reboot the system which will render a display loss during the rebooting process. this is a still image capture system without any direct patient contact.

Device

VP 1600 HD STILL CAPTURE SYSTEM
  • Modelo / Serial
    Model Catalog: VP1600 (Lot serial: All serial numbers)
  • Descripción del producto
    HD STILL CAPTURE SYSTEM
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC