Events

Retiro De Equipo (Recall) de Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Healthcare Informatics, Inc..

¿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
    68262
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1646-2014
  • Fecha de inicio del evento
    2014-05-05
  • Fecha de publicación del evento
    2014-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127235
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Medical device data system - Product Code OUG
  • Causa
    When using xiris rio version (8.1.50.0) in conjuncture with isite pacs a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed.
  • Acción
    Philips Healthcare sent an Urgent Field Safety Notice dated May 5, 2014. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the synchronization problem and request that a copy of this notification be kept with the equipment instructions for use. The document goes on to outline the affected product, the problems and conditions when it can occur. A photo of the label for easy identity the actions to be taken are provided. Philips is informing users of the issue via the notification and will deploy a software correction to all customers when available. Questions may be directed to Philips reps or Care at 1-866-946-4701 or OneEMSProd@philips.com

Device

Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50
  • Modelo / Serial
    Model XIRIS 8.1 version XIRIS 8.1.50.0
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
  • Descripción del producto
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 || XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • Dirección del fabricante
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA