Events

Retiro De Equipo (Recall) de Slit Lamp

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss 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-2017-RN-01150-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-09-04
  • 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-2017-RN-01150-1
  • 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
    Based on post market surveillance activities, carl zeiss has determined that in certain devices there is an increased probability of failure of the power supply on/off switch, and surface corrosion of the mirror which changes the direction of the light projection. there is no potential health hazard and the probability of injury is extremely unlikely. in a worst case scenario, a burning smell may result from a thermal event at the power supply on/off switch. issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. the slit projection may be slightly darker and more diffused.
  • Acción
    Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.

Device

Slit Lamp
  • Modelo / Serial
    Slit LampModel Number: SL 220 Serial Numbers: 970712XXXX and 970714XXXXARTG Number: 94353
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd