Events

Retiro De Equipo (Recall) de ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConMed Linvatec 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
    Recall
  • ID del evento
    RC-2013-RN-00224-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-03-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00224-1
  • 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 determined there is potential for the keyboard to lockup during operation due to a software issue in the vp1600 console. if during use the caps lock/num lock is pressed, the vp1600 software could potentially give the appearance of being locked up, but is actually unresponsive only to keyboard inputs. the vp1600 is still presenting a live image on the main display but may not be able to capture an image frame for record storage using the keyboard.
  • Acción
    Please contact ConMed Linvatec Australia to schedule a return date for repairing the affected unit. A loan unit will be provided by ConMed Linvatec if needed during the repair. VP1600 can continued to be used until repaired if the manufacturer’s recommendations and instructions detailed in the Product Manual, for the safe handling and use of the device is followed.

Device

ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)
  • Modelo / Serial
    ConMed Linvatec VP1600 HD Still Capture Image System (Endoscopic video imaging system)Affected Serial numbers: 75659, 75804, 76126, 75805, 76116, 12008, 72902, 76009, 12043, 12036, 75657, 75658 and 12015ARTG: 126243
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd