Retiro De Equipo (Recall) de Device Recall Stryker MA204

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 Stryker Medical Division of Stryker Corporation.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    An adverse trend of scale and bed exit service reports/complaints were detected for the gobed+, gobed ii, rose, and ma204 model beds. investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. the scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac.
  • Acción
    The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).


  • Modelo / Serial
    Model FL25E: QK02276, QK02274, QK01602, KK01602, K03922, K03921, K03920, K03919, K03918, K03917, K03916, K03915, K03914, K03913, K03912, K03911, K03910, K03909, K03908, K03907, K03906, K03905, K03904, K03903, K03902, K03901, K03900, K03899, K03898, K03897, K03896, K03895, K03894, K03893, K03892, K03891, K03890, K03889, K03888, K03887, K03886, K03885, K03884, K03883, K03882, K03881, K03880, K03879, K03878, K03877, K03876, K03875, K03874, K03873, K03872, K03871, K03870, K03869, K03868, K03867, K03866, K03865, K03864, K03863, K03862, K03861, K03860, K03859, K03858, K03857, K03856, K03855, K03854, K03853, K03852, K03851, K03850, K03849, K03848, K03847, K03846, K03845, K03844, K03843, K03842, K03841, K03840, K03839, K03838, K03837, K03836, K03835, K03834, K03833, K03832, K03831, K03830, K03829, K03828, K03827, K03826, K03825, K03824, K03823, K03822, K03821, K03820, K03819, K03818, K03817, K03816, K03815, K03814, K03813, K03812, K03811, K03810, K03809, K03808, K03807, K03806, K03805, 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K01281, K01280, K01279, K01278, K01277, K01276, K01275, K01274, K01273, K01272, K01271, K01270, K01269, K01268, K01267, K01266, K01265, K01264, K01263, K01262, K01261, K01260, K01259, K01258, K01257, K01256, K01255, K01254, K01253, K01252, K01251, K01250, K01249, K01248, K01247, K01246, K01245, K01244, K01243, K01242, K01241, K01240, K01239, K01238, K01237, K01236, K01235, K01234, K01233, K01232, K01231, K01230, K01229, K01228, K01227, K01226, K01225, K01224, K01223, K01222, K01221, K01220, K01219, K01218, K01217, K01216, K01215, K01214, K01213, K01212, K01211, K01210, K01209, K01208, K01207, K01206, K01205, K01204, K01203, K01201, K01197, K01196, K01195, K01194, K01193, K01192, K01191, K01190, K01189, K01188, K01187, K01186, K01185, K01184, K01183, K01182, K01181, K01180, K01179, K01178, K01177, K01176, K01175, K01174, K01173, K01172, K01171, K01170, K01169, K01168, K01167, K01166, K01165, K01164, K01163, K01162, K01161, K01160, K01159, K01158, K01157, K01156, K01155, K01154, K01153, K01152, K01151, K01150, K01149, K01148, K01147, K01146, K01145, K01144, K01143, K01142, K01141, K01140, K01139, K01138, K01137, K01136, K01135, K01134, K01133, K01132, K01131, K01130, K01129, K01128, K01127, K01126, K01125, K01124, K01123, K01122, K01121, K01120, K01119, K01118, K01117, K01116, K01115, K01114, K01113, K01112, K01111, K01110, K01109, K01108, K01107, K01106, K01105, K01104, K01103, K01102, K01101, K01100, K01099, K01098, K01097, K01096, K01095, K01094, K01093, K01092, K01091, K01090, K01089, K01088, K01087, K01086, K01085, K01084, K01083, K01082, K01081, K01080, K01079, K01078, K01077, K01076, K01075, K01074, K01073, K01072, K01071, K01070, K01069, K01068, K01067, K01066, K01065, K01064, K01063, K01062, K01061, K01060, K01059, K01058, K01057, K01056, K01055, K01054, K01053, K01052, K01051, K01050, K01049, K01048, K01047, K01046, K01045, K01044, K01043, K01042, K01041, K01040, K01039, K01038, K01037, K01036, K01035, K01034, K01033, K01032, K01031, K01030, K01029, K01028, K01027, K01026, K01025, K01024, K01022, K01021, K01020, K01019, K01018, K01017, K01016, K01013, K00064, K00063, K00062, K00061, K00060, K00058, K00056, K00055, K00054, K00053, K00052, K00051, K00050, K00049, K00048, K00047, K00046, K00045, K00044, K00043, K00042, K00041, K00040, K00039, K00038, K00037, K00036, K00035, K00034, K00033, K00032, K00031, K00030, K00029, K00005, K00004, and K00000.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.
  • Descripción del producto
    Stryker MA204 Bed Model (FL25E) || Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
  • Manufacturer


  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Empresa matriz del fabricante (2017)
  • Source