Events

Retiro De Equipo (Recall) de Device Recall TraumaDiagnost

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
    71764
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0766-2016
  • Fecha de inicio del evento
    2015-07-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138999
  • 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
    System, x-ray, stationary - Product Code KPR
  • Causa
    If arm is not fastened securely it could fall down.
  • Acción
    Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. For questions, contact your local representative or use the Technical Support Line at 1-800-722-9377. When communicating with Philips regarding this issue, please reference Field Change Order 72000014.

Device

Device Recall TraumaDiagnost
  • Modelo / Serial
    All TraumaDiagnost products that were delivered before the week of July 2, 2007.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
  • 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