Events

Recall of Device Recall Stryker Rose Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61712
  • Event Risk Class
    Class 2
  • Event Number
    Z-1861-2012
  • Event Initiated Date
    2012-05-17
  • Event Date Posted
    2012-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109326
  • Notes / Alerts
    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.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 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.
  • 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).

Device

Device Recall Stryker Rose Bed
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA