Events

Retiro De Equipo (Recall) de BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)

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-2016-RN-00051-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-18
  • 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-2016-RN-00051-1
  • 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 have identified 4 issues with the brightview systems:1. during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan. although unlikely, if the collision sensors malfunction & the operator fails to activate the e-stop, this could lead to serious bodily injury for the patient.2. during a scan, the gantry motion may halt prematurely. this causes the scan sequence to pause.3. operator will receive a warning message that the scan may not complete & re-mark the points used to define the orbit when defined with a detector relative angle of 90 & head first supine/feet first prone setting. 4. resolved defects section of user release document 1.2.4/2.5.4 for brightview, brightview x & xct listed 2 pre-programmed motions (ppms) whose motion sequences were changed by the release of s/w v1.2.4/ 2.5.4.
  • Acción
    The sponsor will provide a system software upgrade to correct the reported issues.

Device

BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (ver...
  • Modelo / Serial
    BrightView X/XCT/XCT Upgrade 882480: BrightView (version 1.2.3 or 1.2.4)882478: BrightView X (version 2.5.3 or 2.5.4)882482: BrightView XCT (version 2.5.3 or 2.5.4)882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)ARTG Numbers: 117642 and 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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