Events

Retiro De Equipo (Recall) de Essenta DR Compact (General purpose X-ray 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 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-2012-RN-00787-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-03
  • 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-2012-RN-00787-3
  • 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
    Three issues requiring correction have been identified by the manufacturer:1. during reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. the safety catch mechanism does not activate due to the counteracting force of the remaining spring. as a consequence the u-arm moves down uncontrolled. the manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system. 2. during installation all 3 screws for one sib chain wheel were found loose. if all 3 screws of one of these wheels loosen completely, the detector carriage and/or the tube carriage can move down uncontrolled until stopped by the corresponding end stop.3. during in-house testing it was detected that the life time of the wire rope is significantly lower than the specified 10 years. the replacement of the wire rope every 3 years is required.
  • Acción
    Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and Instructions for Use.

Device

Essenta DR Compact (General purpose X-ray system)

Manufacturer

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