Events

Retiro De Equipo (Recall) de IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical 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 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
    Recall
  • ID del evento
    RC-2013-RN-01127-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-12
  • 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-01127-1
  • 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, intuitive surgical has identified that the metalized coating on the is3000 hd lamp module (pn ins-950093-05) may be incompatible with the illuminator (pn ins-951183-06) control board, leading to a red preventive maintenance advisory (pma) that shows up on all monitors and cannot be dismissed by the user. in rare circumstances the illuminator may be damaged or the lamp module might not illuminate. there have been no reports of lamp failures associated with this issue.
  • Acción
    Device Technologies is advising users that this issue does not affect lamps with plastic coating. Affected lamps with metal finish may continue to be used until a replacement is received. If an error message is displayed, users should contact their Device Technologies representative.

Device

IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci S...
  • Modelo / Serial
    IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)Part Number (PN): INS-950093-05ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd