Events

Retiro De Equipo (Recall) de BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16

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-2018-RN-00049-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-15
  • 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-2018-RN-00049-1
  • 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 has identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.
  • Acción
    Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange. Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system. It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera. It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU. Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.

Device

BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
  • Modelo / Serial
    BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16Product Number - 8823500 Precedence 16Product Number - 882351 Precedence 6 SliceProduct Number - 882478 BrightView X Product Number - 882480 BrightView SPECTProduct Number - 882482 BrightView XCTARTG Number: 117440 (Philips Electronics Australia Ltd - SPECT/CT diagnostic imaging system)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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