Events

Retiro De Equipo (Recall) de BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging 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-2016-RN-00787-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-14
  • 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-00787-1
  • 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
    During a non-auto body contouring (abc), non-circular, rel-180 scan, the detector may come in contact with the patient. if this occurs, contact sensors would pause the scan. a certain set of conditions identified in the customer letter are required to create the situation. there have been no reports of any injuries associated with this issue. however, users are reminded to ensure patients are observed closely at all times, and the e-stop is activated to prevent contact with the patient, if required.
  • Acción
    Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.

Device

BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear...
  • Modelo / Serial
    BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)Model numbers: 882478, 882482ARTG numbers: 117642, 17440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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