Events

Retiro De Equipo (Recall) de BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging 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-2014-RN-00035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-20
  • 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-00035-1
  • 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
    Several software issues were identified which will be corrected with the release of a new software version. 1. when positioning for a relative 180 degree non-circular acquisition, if the second (bottom) detector is not positioned correctly, it may result in an inappropriate rotation orbit calculation for the patient being imaged. this may result in the detectors coming in contact with the patient.2. as the gantry system moves to a relative 90 degree scan position of the detectors, a patient/operator may move their hands or arms into the path of the detectors, resulting in contact with the patient/operator. 3. when a user manually positions the patient for an exam and is translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet which may result in a pinch point or table tilt if not engaged with the catcher. this problem can only occur on the brightview x or the brightview xct system.
  • Acción
    Philips Healthcare is advising users to always follow the Instruction For Use (IFU), and is providing additional instructions to prevent the issues from occurring. A software upgrade will be installed on all affected systems as a permanent correction for the issues.

Device

BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)
  • Modelo / Serial
    BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)BrightView SPECTProduct Code: 882480BrightView XProduct Code: 882478BrightView XCTProduct Code: 882482ARTG Numbers: 117642 and 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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