Events

Retiro De Equipo (Recall) de Device Recall MultiDiagnost Eleva

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 Medical Systems Nederlands.

¿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
    79783
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1605-2018
  • Fecha de inicio del evento
    2018-03-26
  • 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=163434
  • 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, angiographic - Product Code IZI
  • Causa
    The fixation of the upper and lower tilt actuator, of the md-eleva system might break off and the table will start to rotate from 0 to + 90 i- 90 degree with high speed. this rotating movement cannot be stopped by the user.
  • Acción
    The firm, BU IGT Systems, sent an "URGENT- Field Safety Notice" letter dated 3/23/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the system and call your Philips representative if the following situations occurs: -the table height or tilt movement is not working. - you notice a cracking or snapping sound during system operation. - you experience a blockade in the table height or tilt movement during system movements. -the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. - you have used a CPR stand that obstructed the system, or - you notice any (other) unusual system behavior beyond the normal use of the system. The customers should also avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. In addition, ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. The firm stated: -All possibly affected products in the field will be corrected by means of a field change order free of charge. -A firm representative will replace affected material on the upper and lower tilt actuator in the affected systems. -You will be contacted by our local Philips representative to schedule this corrective action. -This action will start effective April 2018. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.

Device

Device Recall MultiDiagnost Eleva
  • Modelo / Serial
    System Serial #  18 42 46 41 36 35 37 47 27 43 10 5 24 29 34 49 26 13 15 25 50 12 17 48 32 30 31 14 40 19 9 16 45 8 4 21 11
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    MultiDiagnost Eleva 708036 || As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Dirección del fabricante
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA