Events

Retiro De Equipo (Recall) de Allura Xper, Allura Clarity & Integris

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-2015-RN-01124-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-17
  • 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-2015-RN-01124-1
  • 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 user may misinterpret still images as live images under following circumstances:1. if while performing fluoroscopy, the user also depresses the single shot exposure pedal, resulting in a single shot still image being acquired and displayed on the screen. the live fluoroscopy is not resumed until the single-shot exposure pedal is released. 2. on systems with multiple fluoroscopy pedals and modes (such as biplane systems), if while fluoroscopy is active in one mode, the user also depresses a second fluoroscopy pedal for a different mode and then releases the first fluoroscopy pedal, the system will stop live imaging and display a still last image hold ) image.Then the device ignores the second pedal until both fluoroscopy pedals have been released.Mistakenly interpreting still images as live images during interventional or diagnostic procedures can lead to unintended positioning of interventional and diagnostic devices and potentially resulting in patient injury or death.
  • Acción
    Philips is advising the users to follow the instructions given in the customer letter and the IFU when operating the device as follows: - Be aware of the indicators related to X-ray on as described in the Instructions for Use (IFU). - Be aware that it is not possible to perform fluoroscopy and exposure at the same time. - USE ONLY ONE PEDAL at a time for image acquisition OR live imaging. - Be aware that pressing a single shot exposure pedal results in a still exposure image being displayed. No new image is acquired as long as the single shot exposure pedal remains pressed. - Always release the activated x-ray pedal after completion of image acquisition. - Philips recommends the usage of an audible signal (X-ray buzzer) during live imaging. If your X-ray buzzer has been disabled, contact Philips if you decide to enable it as an additional safety precaution. Philips is working with the TGA to determine whether any further risk mitigation actions are required. This action has been closed-out on 04/05/2017.

Device

Allura Xper, Allura Clarity & Integris
  • Modelo / Serial
    Allura Xper, Allura Clarity & IntegrisMultiple Product names affectedAllura System product codes 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722034, 722035, 722038, 722039, 722058, 722400.Integris product codes72238, 72239, 72240, 72241, 72242, 72243 ,72244, 72245, 72246, 72247, 72248, 72249, 722021, 722030, 722043, 722044ARTG # 175708, 98560
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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