Events

Device Recall Stryker Rose Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Medical Division of Stryker Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61712
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1861-2012
  • 사례 시작날짜
    2012-05-17
  • 사례 출판 날짜
    2012-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109326
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA