Events

Retiro De Equipo (Recall) de Device Recall MOSAIQ OIS

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
    75853
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0731-2017
  • Fecha de inicio del evento
    2016-12-02
  • 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=151455
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Edits to particle field definition parameters may not be saved when the field definition window is saved.
  • Acción
    The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter dated 11/2016 was sent to affected customers on 12/2/2016. The letter describes the product, problem and actions to be taken. The customers were instructed to save and re-open the field definition form when manual edits have been performed to confirm that the edits were save; post this notice in a place accessible to all users; advise the appropriate personnel working with the product the content of the letter; and complete and return the Acknowledgement Form via fax to: 408 830 8003 immediately upon receipt but no later than 30 days. Elekta will resolve the problem with the MOSAIQ 2.60 SP7F, MOSAIQ 2.60 SP14 and 2.64 SP3. Customers are encouraged to contact Elekta support to get the corrected version. If you have any questions, contact RA Manager Americas at 1-770-300-9725 or email to: Elekta_Global_PMS@elekta.com.

Device

Device Recall MOSAIQ OIS
  • Modelo / Serial
    Versions 2.60 an higher
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden and United Kingdom.
  • Descripción del producto
    MOSAIQ Oncology Information System || The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
  • 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