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Recall Observatory FDA recall evidence

Device product

Stryker Rose Bed Model (FL14E) 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

Z-1861-2012

May 17, 2012

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 61712
Status
Terminated
Classification
Class II
Quantity
999
Official record key
device-enforcement:Z-1861-2012

Official wording

Reason: 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

Code information: Model FL14E: Serial Number QB22371, QB22370, QB22369, QB22368, QB22367, QB21200, QB18330, QB17733, B22524, B22523, B22522, B22521, B22506, B22505, B22504, B22503, B22502, B22501, B22500, B22446, B22445, B22444, B22443, B22442, B22441, B22440, B22439, B22438, B22437, B22436, B22435, B22427, B22426, B22425, B22424, B22423, B22422, B22421, B22420, B22419, B22373, B22372, B22308, B22307, B22306, B22305, B22304, B22303, B22302, B22301, B22300, B22299, B22298, B22297, B22296, B22295, B22294, B22293, B22292, B22291, B22290, B22289, B22247, B22246, B22245, B22244, B22243, B22242, B22241, B22240, B22239, B22238, B22237, B22236, B22235, B22234, B22233, B22232, B22231, B22230, B22229, B22228, B22227, B22226, B22225, B22224, B22223, B22222, B22221, B22220, B22219, B22218, B22217, B22216, B22215, B22214, B22213, B22212, B22211, B22210, B22209, B22208, B22207, B22206, B22205, B22204, B22203, B22202, B22201, B22200, B22199, B22198, B22197, B22196, B22195, B22194, B22193, B22192, B22191, B22190, B22189, B22188, B22187, B22186, B22185, B22184, B22172, B22171, B22170, B22169, B22168, B22167, B22166, B22165, B22164, B22163, B22162, B22161, B22160, B22159, B22158, B22157, B22156, B22120, B22119, B22118, B22117, B22116, B22115, B22114, B22113, B22112, B22111, B22110, B22109, B22108, B22107, B22106, B22105, B22104, B22103, B22102, B22101, B22100, B22099, B22098, B22097, B22096, B22095, B22094, B22093, B22092, B22091, B22090, B22089, B22088, B22087, B22086, B22085, B22084, B22083, B22082, B22081, B22080, B22079, B22078, B22077, B22076, B22075, B22074, B22073, B22072, B22071, B22070, B22069, B22068, B22067, B22066, B22065, B22064, B22063, B22062, B22061, B22060, B22059, B22058, B22057, B22056, B22055, B22054, B22053, B22052, B22051, B22050, B22049, B22048, B22047, B22046, B22045, B22044, B22043, B22042, B22041, B22040, B22039, B22038, B22037, B22036, B22035, B22034, B22033, B22032, B22031, B22030, B22029, B22028, B22027, B22026, B22025, B22024, B22023, B22022, B22021, B22020, B22019, B22018, B22017, B22016, B22015, B22014, B22013, B22012, B21975, B21974, B21973, B21972, B21971, B21970, B21969, B21968, B21967, B21966, B21965, B21964, B21963, B21962, B21961, B21960, B21959, B21958, B21898, B21897, B21896, B21895, B21894, B21893, B21892, B21891, B21890, B21810, B21809, B21808, B21807, B21806, B21805, B21804, B21803, B21787, B21786, B21785, B21784, B21783, B21782, B21781, B21780, B21779, B21744, B21743, B21742, B21741, B21740, B21739, B21738, B21737, B21736, B21735, B21734, B21733, B21732, B21731, B21730, B21729, B21728, B21727, B21726, B21725, B21724, B21723, B21722, B21721, B21720, B21719, B21718, B21717, B21716, B21715, B21714, B21713, B21712, B21711, B21710, B21709, B21708, B21707, B21706, B21705, B21704, B21703, B21702, B21701, B21700, B21699, B21698, B21697, B21696, B21695, B21694, B21634, B21633, B21632, B21631, B21630, B21629, B21628, B21627, B21626, B21625, B21624, B21623, B21622, B21621, B21620, B21619, B21618, B21595, B21594, B21593, B21592, B21591, B21590, B21589, B21588, B21587, B21586, B21585, B21584, B21583, B21582, B21581, B21580, B21579, B21578, B21577, B21576, B21575, B21574, B21549, B21514, B21513, B21512, B21501, B21500, B21499, B21498, B21497, B21496, B21495, B21494, B21493, B21473, B21472, B21471, B21470, B21469, B21468, B21467, B21466, B21465, B21464, B21463, B21385, B21384, B21383, B21382, B21381, B21380, B21379, B21378, B21348, B21347, B21346, B21345, B21344, B21343, B21342, B21341, B21340, B21339, B21338, B21337, B21336, B21335, B21334, B21316, B21315, B21314, B21313, B21312, B21302, B21301, B21300, B21299, B21298, B21297, B21296, B21295, B21294, B21293, B21292, B21291, B21290, B21207, B21206, B21205, B21204, B21203, B21202, B21201, B21199, B21198, B21197, B21196, B21195, B21189, B21188, B21187, B21186, B21185, B21184, B21183, B21182, B21181, B21180, B21143, B21142, B21141, B21140, B21139, B21138, B21137, B21136, B21135, B21134, B21133, B21132, B21131, B21075, B21074, B21073, B21072, B21071, B21070, B20969, B20968, B20967, B20966, B20965, B20964, B20963, B20962, B20961, B20960, B20959, B20958, B20957, B20956, B20955, B20954, B20943, B20942, B20941, B20940, B20939, B20938, B20937, B20936, B20935, B20934, B20933, B20932, B20931, B20930, B20929, B20928, B20927, B20926, B20925, B20924, B20923, B20922, B20921, B20920, B20919, B20918, B20917, B20916, B20915, B20914, B20913, B20912, B20911, B20910, B20909, B20908, B20907, B20906, B20905, B20904, B20903, B20902, B20901, B20900, B20899, B20898, B20897, B20896, B20895, B20894, B20893, B20892, B20891, B20890, B20889, B20866, B20865, B20764, B20763, B20762, B20761, B20760, B20759, B20758, B20757, B20756, B20755, B20754, B20753, B20752, B20751, B20750, B20749, B20748, B20747, B20746, B20745, B20744, B20676, B20675, B20674, B20673, B20672, B20671, B20670, B20669, B20589, B20588, B20587, B20586, B20585, B20584, B20583, B20582, B20581, B20580, B20579, B20578, B20577, B20576, B20575, B20513, B20512, B20511, B20465, B20444, B20443, B20442, B20441, B20440, B20439, B20438, B20437, B20436, B20435, B20434, B20266, B20265, B20264, B20263, B20184, B20183, B20182, B20181, B20180, B20179, B20178, B20177, B20176, B20175, B20174, B20173, B20172, B20171, B20170, B20169, B20168, B20167, B20166, B20165, B20002, B20001, B20000, B19999, B19998, B19997, B19996, B19995, B19994, B19993, B19992, B19991, B19591, B19590, B19589, B19588, B19587, B19586, B19585, B19584, B19583, B19431, B19430, B19429, B19428, B19427, B19426, B19425, B19424, B19302, B19301, B19300, B19299, B19298, B19297, B19296, B19295, B19294, B19293, B19292, B19291, B19290, B19289, B19288, B19287, B19286, B19285, B19284, B19283, B19282, B19281, B19280, B19279, B19278, B19277, B19276, B19275, B19274, B19273, B19272, B19271, B19270, B19269, B19268, B19267, B19266, B19265, B19264, B19263, B19262, B19261, B19260, B19259, B19258, B19257, B19256, B19255, B19254, B19253, B19252, B19251, B19250, B19249, B19248, B19247, B19246, B19245, B19244, B19243, B19242, B19241, B19240, B19239, B19238, B19237, B19236, B19235, B19234, B19233, B19232, B19231, B19230, B19125, B19124, B19123, B19122, B19121, B19120, B19119, B19118, B19117, B19116, B19115, B19114, B19113, B19112, B19111, B19110, B19109, B19108, B19107, B19106, B19105, B19104, B19103, B19102, B19101, B19100, B19099, B19098, B19097, B19096, B19066, B19065, B19064, B19063, B19062, B19061, B19060, B19059, B19058, B19057, B19056, B19055, B19054, B19053, B19052, B19051, B19050, B19049, B19048, B19047, B19046, B19045, B19044, B19043, B19042, B19041, B19040, B19039, B19038, B19037, B19036, B18984, B18983, B18982, B18981, B18980, B18978, B18977, B18976, B18975, B18974, B18952, B18951, B18949, B18948, B18947, B18941, B18884, B18883, B18882, B18881, B18880, B18879, B18878, B18877, B18876, B18875, B18874, B18873, B18872, B18835, B18834, B18833, B18832, B18831, B18830, B18829, B18828, B18827, B18826, B18825, B18824, B18823, B18822, B18821, B18820, B18819, B18706, B18705, B18704, B18703, B18702, B18701, B18700, B18699, B18698, B18697, B18696, B18695, B18694, B18693, B18692, B18691, B18690, B18689, B18688, B18687, B18686, B18685, B18684, B18683, B18670, B18669, B18668, B18667, B18666, B18575, B18574, B18573, B18561, B18560, B18488, B18487, B18486, B18485, B18484, B18483, B18482, B18481, B18480, B18479, B18478, B18477, B18476, B18475, B18474, B18331, B18205, B18204, B18203, B18202, B17830, B17829, B17824, B17759, B17739, B17738, B17737, B17736, B17735, B17734, B17683, B17682, B17681, B17680, B17679, B17678, B17677, B17676, B17675, B17616, B17615, B17614, B17613, B17612, B17611, B17610, B17461, B17334, B17333, B17332, B17331, B17330, B17295, B17294, B17293, B17292, B17179, B17178, B17177, B16999, B16998, B16997, B16996, B16995, B16994, B16934, B16933, B16932, B16931, B16731, B16730, B16729, B16728, B16727, B16726, B16725, B16724, B16723, B16702, B16701, B16700, B16699, B16698, B16697, B16696, B16695, B16694, B16693, B16692, B16691, B16690, B16689, B16682, B16641, B16640, B16639, B16638, B16637, B16341, B16340, B16339, B16338, B16015, B16014, B16013, B16012, B16011, and B16010

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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