Events

Retiro De Equipo (Recall) de Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1

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 Electronics North America Corporation.

¿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
    71838
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2383-2015
  • Fecha de inicio del evento
    2015-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139186
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    The system is designed to emit a beep upon termination of an exposure. however, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the microsoft windows 7 operating system.
  • Acción
    Philips Healthcare sent an Urgent Field Safety Notice letter dated June 25, 2015 to customers. The letter identified the affected product, problem and actions to be taken. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your local philips representative.

Device

Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1
  • Modelo / Serial
    DigitalDiagnost
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
  • Descripción del producto
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 || Product Usage: || The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA