Events

Retiro De Equipo (Recall) de Device Recall PrecisePLAN 2.10 Treatment Planning System

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
    55100
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1406-2010
  • Fecha de inicio del evento
    2006-03-15
  • Fecha de publicación del evento
    2010-04-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89893
  • 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
    Medical changed particle radiation therapy system - Product Code MUJ
  • Causa
    Error in dose rates which were calculated at exactly twice the expected values.
  • Acción
    As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken. Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.

Device

Device Recall PrecisePLAN 2.10 Treatment Planning System
  • Modelo / Serial
    1762685762, 1762688017, 1762688506, 1726288507, 1762676911, 1762688175, 1762689384, 1762688019, 1762688022, 1762688876, 1762689442, 1762688177, 1762690813, 1762686657, 1762689588, 1762689386, 1762684357, 1762686833, 1762684370, 1762678238, 1762689519, 1762684359, 1762690814, 1762688514, 1762578223, 1762678239, 1762684360, 1762684361, 1762684362, 1762684367, 1762683737, 1762682414, 1762688081, 1762686584, 1762686843, 1762686832, 1762688024, 1762688080, 1762686836, 1762684358
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland
  • Descripción del producto
    PrecisePLAN 2.10 Treatment Planning System
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA