Events

Retiro De Equipo (Recall) de ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

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
    55099
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1411-2010
  • Fecha de inicio del evento
    2007-09-19
  • Fecha de publicación del evento
    2010-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89892
  • 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 (with patient imaging) - Product Code IYE
  • Causa
    Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.
  • Acción
    The following Important Notices were sent to customers: 1) Important Notice A305-Possible Synergy XVI panel position error (dated September 19, 2007) was sent to customers with versions R3.5, R4.0 and R4.1., 2) Important Notice A306-Possible Synergy XVI panel positioning error (dated November 8, 2007) was released to encompass customers with version R4.2., and 3) Important Notice A328 dated March 10, 2009, and sent again on April 29, 2009, included a modification kit to address the original issue and an expanded range of serial numbers affected. This Important notice A328 entitled, Elekta Synergy kV Detector Position Readback Modification Kit supersedes A305 and A306 for customers who have serial numbers within the range specified. The letter describes the product and the problem and advises the customer to follow any instructions or recommendations covered in this Notice. If you have any questions, please contact Elekta at 770-670-2548.

Device

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
  • Modelo / Serial
    134351, 134524, 134723, 135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135068, 135071, 135072, 135073, 135076, 135078, 135079, 135081, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135104, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135133, 135142, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135225, 135226, 135227, 135230, 135233, 135235, 135237, 135241, 135247, 135251, 135256, 135258, 135259, 135262, 135265, 135267, 135271, 135272, 135273, 135274, 135277, 135278, 135284, 135285, 135287, 135288, 135291, 135292, 135296, 135298, 135300, 135303, 135305, 135306, 135313, 135316, 135323, 135324, 135326, 135328, 135331, 135332, 135334, 135335, 135336, 135337, 135340, 135341, 135343, 135346, 135347, 135348, 135351, 135352, 135353, 135355, 135356, 135359, 135361, 135367, 135368, 135382, 135383, 135384, 135389, 135391, 135393, 135394, 135412, 135413, 135420, 135446, 135455, 136125, 136126, 136127, 136176, 136244
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and Puerto Rico, Canada and Mexico.
  • Descripción del producto
    Elekta Synergy XVI || The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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