Events

Retiro De Equipo (Recall) de ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2014-RN-00405-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-01
  • 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-2014-RN-00405-1
  • 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
    Philips healthcare received a report from the field about an adac vertex plus system. during clinical use in the relative 180 degree configuration of the detector heads, the radius drive belt in the superior positioned head slipped off the idler pulley, allowing the detector head to drift down slowly (approximately 1 cm per minute) towards the patient. this resulted in the operator having to perform an emergency removal of the patient from the system. there have been no reports of serious injury or death as a result of this situation.
  • Acción
    Hospitals are requested to cease use of "Relative 180 degree SPECT" and "pinhole collimator" procedures until the implementation of the correction. Philips will replace the two radius drive belts and idler pulleys to correct the problem.

Device

ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA