Events

Retiro De Equipo (Recall) de BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT 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-2017-RN-00327-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-03-06
  • 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-2017-RN-00327-1
  • 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
    The detector braking systems may be rendered ineffective resulting in one or both detectors moving to their mechanical limit. in the case of this kind of failure, the detector motion cannot be halted using normal operator intervention (e-stop, collimator contact sensor activation). the detector(s) may move down onto the patient or operator, potentially resulting in entrapment and/or serious injury or death. any brightview, brightview x or brightview xct where components on the braking system have been serviced is potentially affected. systems that were serviced and received a complete brake assembly are not affected by this issue.
  • Acción
    Customers are advised to immediately discontinue use of the system until Philips Service has undertaken the inspection of the system. The system can be returned for clinical use if the system brakes pass inspection. If the system brakes fail inspection, the system will be returned for clinical use once the correction is implemented.

Device

BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nucl...
  • Modelo / Serial
    BrightView, BrightView X and BrightView XCT with Tangential, Radius, and Roll drive assembly(Nuclear medicine gamma camera and SPECT/CT systems)Affected component(s) or subsystem(s):Radius DrivePart Numbers: 453560304611, 453560312361, 453560303641Tangent DrivePart Numbers: 453560304611, 453560312361, 453560303761Roll DrivePart Numbers: 453560313601, 453560303781, 453560313881ARTG Numbers: 117642, 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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