Events

Retiro De Equipo (Recall) de HexaPOD evo RT Couchtop

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
    68088
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1514-2014
  • Fecha de inicio del evento
    2014-04-17
  • Fecha de publicación del evento
    2014-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126923
  • 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
    If screws are not properly tightened with a torque wrench they may become loose over time.
  • Acción
    Corrective Action #1 - Important Field Safety Notice 618 01 302 002 was issued April 2014. The Notice informs end users about the problem and the potential clinical impact. It also give a recommendation how the risk can be mitigated - inspect the screws and if loose contact Elekta Service to tighten the screws with 20 Nm. The notice also advises the customer that a modification kit will be released that introduces an improved screw solution. The solution will be implemented on all affected products when available. Corrective Action #2 Permanent Solution - Replace Current Screws - An improved screw has been designed and will be available for Elekta Field Service organization to replace on all affected products at the end of April. The new design solution provides a very long used thread depth, exceeding the standard recommended thread-depths by far. This design will prevent the screws from loosening.

Device

HexaPOD evo RT Couchtop
  • Modelo / Serial
    Serial Numbers  42188, 42246, 42106, 42153, 42107, 42068, 42012, 42013, 42062, 42009, 42224, 42126, 3005, 42222, 3019, 3000, 42058, 42059, 42057, 42187, 42129, 42159, 3022, 3017, 42189, 42213, 42202, 42212, 42004, 4220, 42113, 42178, 42216, 42207, 2982, 2986, 2991, 42102, 42000, 42032, 42145, 42174, 42008, 42048, 42064, 42070, 42074, 42084, 42115, 42134, 42118, 42152, 42137, 42146, 3008, 2987, 3010, 3018, 42069, 42036, 3029, 42162, 42139, 42011, 42007, 42173, 42109, 42193, 3006, 42053, 42015, 42105, 42124, 42085, 42065, 42094, 42198, 2998, 3003, 3033, 3024, 2980, 42121, 2999, 42027, 42061, 42075, 42079, 42214, 3020, 42192, 42247, 42202, 42155, 42025, 42021, 42127, 42151, 42239, 42033, 42035, 42089, 42204, 42200, 2995, 3030, 42266, 42197, 42077, 42001, 42037, 42147, 42186, 42016, 42028, 42029, 42050, 42042, 42054, 42047, 42051, 42055, 42049, 42262, 42080, 42076, 42063, 42103, 42087, 42117, 42083, 42166, 42101, 42227, 42150, 42156, 42163, 42179, 42180, 42140, 42165, 42157,42234, 42169, 42182, 42183, 42236, 42195, 42223, 42256, 42276, 42260, 42231, 42250, 42243, 42240, 42272, 42235, 42249, 42254, 42245, 42265, 42268, 42267, 42253, 42264, 2993, 2997, 3004, 3031, 3002, 42226, 42258, 42114, 42081, 42090, 42093, 42133, 42181, 42039, 42116, 3016, 29677, 42010, 42073, 42176, 42164, 42031, 3028, 42041, 42038, 42022, 42034, 42088, 42104, 2976, 2979, 2988, 3011, 3015, 3021, 3027, 42238, 42018, 42135, 42252, 42185, 42273, 42060, 42024, 42006, 42082, 42194, 42263, 42232, 42199, 42170, 42161, 42078, 42158, 2985, 2994, 42120, 3032, 42056, 2969, 3034, 2975, 2972, 2984, 42191, 42225, 42228, 42023, 42143, 42122, 42208, 42230, 42211, 42026, 42206, 42066, 42052, 42014, 42218, 42030, 42040, 42244, 42043, 42044, 42045, 42046, 42123, 42255, 42141, 42125, 42072, 42112, 42210, 42017, 420196, 42020, 42067, 42071, 42097, 42100, 42131, 42144, 42136, 42148, 42130, 42111, 42067, 42171, 42203, 4210, 42205, 42096, 42154, 42241, 42229, 2981, 2989, 2971, 2990, 3007, 3013, 2992, 2973, 2978, 30098, 2974, 3014, 3012, 3025, 2996, 3026, 42274
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, Saudi Arabia, South Korea, Span, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
  • Descripción del producto
    HexaPOD evo RT Couchtop. || To support and aid in positioning a patient during radiation therapy.
  • 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