Events

Retiro De Equipo (Recall) de Device Recall Precise Treatment Table

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 Elekta, 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
    70458
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1238-2015
  • Fecha de inicio del evento
    2015-01-29
  • Fecha de publicación del evento
    2015-03-19
  • 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=133833
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Causa
    It is possible to position the treatment table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. clinical mistreatment may occur if a position error is not detected.
  • Acción
    Planned Action by Elekta: 1. Notifications have been sent out. The notification informs users of the possibility treatment table position errors might occur if there is a maintenance error when replacing a potentiometer. The notification recommends establishing a procedure to verify the accuracy of the treatment table position as shown by the treatment room monitor which is performed as part of the daily machine checks. An example procedure is provided. 2. Elekta will establish a procedure service engineers will follow after maintenance involving the relevant potentiometers to ensure proper installation. The procedure will be taught using a video which includes a step by step guide to the correct methodology for installation of the potentiometer assembly, a description of the impact for not installing correctly, and a guide to the new verification of correct installation procedure. The video will be distributed through Elektas learning management system (LMS). The LMS maintains a record of service engineers who successfully complete the training. 3. Elekta will implement an engineering change to the potentiometer assembly which applies to the manufacture of all new Precise Treatment Tables. This change will eliminate the potential for incorrect installation and will prevent a loose grub screw from causing backlash. This change is expected to consist of a 'D' shaped bore that cannot spin on the shaft of the potentiometer. All actions associated with this correction, including service engineer training, will be completed by June 2015. For further questions please call (770) 300-9725.

Device

Device Recall Precise Treatment Table
  • Modelo / Serial
    Precise Treatment Table Serial Numbers: (124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125966-1256453, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,123318-330, 126338-126373, 126375-397, 126400-133999, 213000+)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland and Syria.
  • Descripción del producto
    Elekta Precise Treatment Table
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA