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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1863-2012

Go Bed II+ Model FL 28 Ex 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

Publicado el 4 de julio de 2012 · Inicio del retiro: 17 de mayo de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Medical Division of Stryker Corporation
Distribuidor
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.
Lote
Model FL28EX, Serial Numbers: QR09842, QM10376, QM10375, QM10374, QM10373, QM10372, QM10371, QM10370, QM10369, QM10368, QM10367, QM10366, QM10365, QM10364, QM10363, QM10362, QM10361, QM10360, QM10359, QM10358, QM10357, QM10356, QM09893, QM09883, QM09829, QM09827, QM09805, QM09804, QM09803, QM09802, QM09801, QM09800, QM09799, QM09798, QM09797, QM09796, QM09795, QM09794, QM09793, QM09444, QM08965, QM08916, QM08832, QM08230, QM08211, QM08210, QM08209, QM08208, QM08207, QM08206, QM08205, QM08204, QM08203, QM08202, QM08201, QM08200, QM08199, QM08198, QM08197, QM08142, QM08136, QM08135, QM08003, QM07962, QM07879, QM07613, QM07451, QM07448, QM07447, QM07446, QM07442, QM07357, QM07149, QM07148, QM07143, QM07141, QM07140, QM06967, QM06830, QM06041, QM06040, QM06039, QM06038, QM06037, QM06036, QM06035, QM06034, QM06033, QM06032, QM06031, QM06030, QM06029, QM06028, QM06027, QM06026, QM06025, QM06024, QM06023, QM06022, QM06021, QM06020, QM06019, QM06018, QM06017, QM06016, QM06015, QM06014, QM06013, QM06012, QM06011, QM06010, QM06009, QM06008, QM06007, QM06006, QM06005, QM06004, QM06003, QM06002, QM05768, QM05764, QM05763, QM05760, QM05675, QM05623, QM05186, QM04126, QM04122, QM04102, QM04099, QM04094, QM04090, QM03452, QM03421, QM03379, QM03200, QM03164, QM03153, QM03149, QM03141, QM03138, QM03137, QM03133, QM02633, QM01900, QM01604, QM01338, QM01325, M13254, M13253, M13252, M13251, M13250, M13249, M13248, M13247, M13246, M13245, M13244, M13243, M13242, M13241, M13240, M13239, M13238, M13237, M13236, M13235, M13234, M13233, M13232, M13231, M13230, M13229, M13228, M13227, M13226, M13225, M13224, M13223, M13222, M13221, M13220, M13219, M13218, M13217, M13216, M13215, M12972, M12971, M12970, M12969, M12968, M12967, M12966, M12965, M12964, M12963, M12962, M12961, M12960, M12959, M12958, M12957, M12956, M12955, M12954, M12953, M12952, M12951, M12950, M12949, M12948, M12947, M12946, M12945, M12944, M12943, M12942, M12941, M12940, M12939, M12938, M12937, M12936, M12935, M12934, M12933, M12923, M12922, M12921, M12920, M12919, M12918, M12917, M12916, M12915, M12914, M12913, M12912, M12911, M12910, M12909, M12908, M12907, M12906, M12905, M12904, M11601, M11600, M11599, M11598, M11597, M11596, M11595, M11594, M11593, M11592, M11591, M11590, M11589, M11588, M11587, M11586, M11585, M11584, M11583, M11582, M11581, M11580, M11579, M11578, M11577, M11576, M10471, M10470, M10469, M10468, M10467, M10466, M10465, M10464, M10463, M10462, M10461, M10460, M10459, M10458, M10457, M10456, M10455, M10454, M10332, M10331, M10330, M10329, M10328, M10327, M10326, M10325, M10324, M10323, M10322, M10321, M10320, M10319, M10318, M10317, M10316, M10315, M10314, M10313, M10312, M10311, M10310, M10309, M10308, M10307, M10306, M10305, M10304, M10303, M10302, M10301, M10300, M10299, M10298, M10297, M10296, M10295, M10294, M10293, M10292, M10291, M10290, M10289, M10288, M10287, M10286, M10285, M10284, M10283, M10282, M10281, M10280, M10279, M10278, M10277, M10276, M10275, M10274, M10273, M10272, M10271, M10270, M10269, M10268, M10267, M10266, M10265, M10264, M10263, M10262, M10261, M10260, M10259, M10258, M10257, M10256, M10255, M10254, M10253, M10252, M10251, M10250, M10249, M10248, M10247, M10246, M10245, M10244, M10243, M10242, M10241, M10240, M10239, M10238, M10237, M10236, M10235, M10234, M10233, M10232, M10231, M10230, M10229, M10228, M10227, M10226, M10225, M10224, M10223, M10222, M10221, M10220, M10219, M10218, M10217, M10216, M10215, M10214, M10213, M10212, M10211, M10210, M10209, M10208, M10207, M10206, M10205, M10204, M10203, M10202, M10201, M10200, M10199, M10198, M10197, M10196, M10195, M10194, M10193, M10192, M10191, M10190, M10189, M10188, M10187, M10186, M10185, M10184, M10183, M10182, M10181, M10180, M10179, M10178, M10177, M10176, M10175, M10174, M10173, M10172, M10171, M10170, M10169, M10168, M10167, M10166, M10165, M10164, M10163, M10162, M10161, M10160, M10159, M10158, M10157, M10156, M10155, M10154, M10153, M10152, M10151, M10150, M10149, M10148, M10147
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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