Class 2 Device Recall Stryker Rose Bed

• Date Initiated by Firm: May 17, 2012
• Date Posted: June 22, 2012
• Recall Status: Terminated on May 12, 2014
• Recall Number: Z-1861-2012
• Recall Event ID: 61712
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• 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
• 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
• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 East Centre Ave.; Portage MI 49002
• For Additional Information Contact: Renata Sila; 269-324-6609
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Component design/selection
• Action: 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).
• Quantity in Commerce: 999
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.