Events

Retiro De Equipo (Recall) de Abbott Medical Optics (AMO) STAR Excimer Laser 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 AMO 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-00567-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-14
  • 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-00567-1
  • 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
    There is the potential for an inadvertent laser firing with no surgeon interaction on the foot pedal due to incorrect output of electrical foot switch buffer when the following conditions are present:1- circuit breaker c9 is tripped open, causing a remote panel pcb power loss2- normal system interlocks are cleared (system waiting for surgeon intervention)there have been no reports of inadvertent firing of the laser in the field.
  • Acción
    Abbott Medical Optics is replacing the circuit board component of all STAR Excimer Laser Systems. The manufacturer has advised that the devices may continue to be used to treat patients. In the unlikely event that the system initiates treatment without direct input, physicians are advised to immediately use the Laser Stop Button located on the doctor's panel as described in the Operators Manual.

Device

Abbott Medical Optics (AMO) STAR Excimer Laser System
  • Modelo / Serial
    Abbott Medical Optics (AMO) STAR Excimer Laser SystemModels: S3, S4 and S4 IR
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd