Events

Device Recall Excel Care ES Bariatric Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom, Inc. 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
    55301
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0333-2011
  • 사례 시작날짜
    2010-03-05
  • 사례 출판 날짜
    2010-11-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90507
  • 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
    The firm received complaints regarding the siderails not operating correctly or becoming inoperable. the siderails could experience false latching, unintentional lowering or become inoperable. there have been reports of 5 patient falls and 2 injuries to caregivers.
  • 조치
    Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.

Device

Device Recall Excel Care ES Bariatric Bed
  • 모델명 / 제조번호(시리얼번호)
    ES213331, ES210RK, ES210OK, ES210525, ES210523, ES210520, ES210517, ES210515, ES210511, ES210504, ES210503, ES210499, ES210495, ES210494, ES210493, ES210492, ES210491, ES210490, ES210489, ES210488, ES210487, ES210486, ES210485, ES210483, ES210481, ES210480, ES210479, ES210478, ES210477, ES210476, ES210475, ES210474, ES210473, ES210472, ES210471, ES210470, ES210468, ES210467, ES210466, ES210465, ES210463, ES210462, ES210461, ES210457, ES210456, ES210455, ES210454, ES210452, ES210451, ES210450, ES21045, ES210449, ES210448, ES210447, ES210446, ES210445, ES210444, ES210443, ES210442, ES210441, ES210440, ES210439, ES210438, ES210437, ES210433, ES210432, ES210431, ES210430, ES210428, ES210427, ES210426, ES210425, ES210424, ES210423, ES210422, ES210421, ES210420, ES210419, ES210418, ES210417, ES210416, ES210415, ES210414, ES210413, ES210412, ES210411, ES210410, ES210409, ES210408, ES210407, ES210406, ES210405, ES210404, ES210403, ES210402, ES210401, ES210400, ES210399, ES210398, ES210397, ES210396, ES210395, ES210394, ES210393, ES210392, ES210391, ES210390, ES210389, ES210388, ES210387, ES210386, ES210385, ES210384, ES210383, ES210378, ES210377, ES210376, ES210375, ES210374, ES210373, ES210372, ES210371, ES210370, ES210369, ES210368, ES210367, ES210366, ES210365, ES210364, ES210363, ES210362, ES210361, ES210360, ES210359, ES210358, ES210357, ES210356, ES210355, ES210354, ES210353, ES210352, ES210351, ES210350, ES210349, ES210348, ES210347, ES210346, ES210345, ES210344, ES210343, ES210342, ES210341, ES210340, ES210339, ES210338, ES210337, ES210336, ES210335, ES210334, ES210333, ES210332, ES210331, ES210330, ES210329, ES210328, ES210327, ES210326, ES210325, ES210324, ES210323, ES210322, ES210321, ES210315, ES210314, ES210313, ES210312, ES210311, ES210310, ES210309, ES210308, ES210307, ES210306, ES210305, ES210304, ES210303, ES210302, ES210301, ES210300, ES210289, ES210288, ES210287, ES210286, ES210285, ES210284, ES210283, ES210282, ES210281, ES210280, ES210279, ES210278, ES210277, ES210276, ES210275, ES210274, ES210273, ES210272, ES210271, ES210270, ES210269, ES210267, ES210266, ES210265, ES210264, ES210263, ES210262, ES210261, ES210259, ES210258, ES210257, ES210256, ES210255, ES210254, ES210253, ES210251, ES210250, ES210249, ES210248, ES210247, ES210246, ES210244, ES210243, ES210242, ES210241, ES210240, ES210239, ES210238, ES210236, ES210235, ES210233, ES210229, ES210228, ES210227, ES210226, ES210225, ES210224, ES210223, ES210222, ES210221, ES210220, ES210213, ES210212, ES210211, ES210210, ES210209, ES210208, ES210207, ES210206, ES210205, ES210204, ES210203, ES210201, ES210199, ES210198, ES210197, ES210196, ES210195, ES210194, ES210193, ES210192, ES210191, ES210190, ES210189, ES210188, ES210187, ES210186, ES210185, ES210184, ES210183, ES210182, ES210181, ES210180, ES210179, ES210178, ES210177, ES210176, ES210175, ES210174, ES210173, ES210172, ES210171, ES210170, ES210169, ES210168, ES210167, ES210166, ES210165, ES210164, ES210163, ES210162, ES210161, ES210160, ES210159, ES210158, ES210157, ES210156, ES210155, ES210154, ES210153, ES210152, ES210151, ES210150, ES210149, ES210148, ES210144, ES210143, ES210142, ES210141, ES210140, ES210139, ES210138, ES210137, ES210136, ES210135, ES210134, ES210133, ES210132, ES210131, ES210130, ES210129, ES210128, ES210127, ES210125, ES210124, ES210123, ES210122, ES210120, ES210119, ES210118, ES210117, ES210116, ES210115, ES210114, ES210113, ES210112, ES210111, ES210110, ES210109, ES210108, ES210107, ES210106, ES210105, ES210104, ES210103, ES210102, ES210101, ES210100, ES210099, ES210098, ES210097, ES210096, ES210095, ES210094, ES210093, ES210092, ES210091, ES210089, ES210088, ES210087, ES210086, ES210085, ES210084, ES210083, ES210082, ES210081, ES210079, ES210078, ES210077, ES210076, ES210075, ES210074, ES210073, ES210072, ES210071, ES210070, ES210069, ES210068, ES210067, ES210066, ES210065, ES210064, ES210063, ES210062, ES210061, ES210060, ES210059, ES210058, ES210057, ES210056, ES210055, ES210054, ES210053, ES210052, ES210051, ES210050, ES210049, ES210048, ES210047, ES210046, ES210045, ES210044, ES210043, ES210042, ES210041, ES210040, ES210039, ES210038, ES210037, ES210036, ES210035, ES210034, ES210033, ES210032, ES210030, ES210029, ES210028, ES210027, ES210026, ES210025, ES210024, ES210023, ES210022, ES210021, ES210020, ES210019, ES210016, ES210015, ES210014, ES210013, ES210012, ES210011, ES210008, ES210006, ES210003, ES20111, ES200956, ES200955, ES200954, ES200953, ES200952, ES200951, ES200950, ES200949, ES200948, ES200947, ES200946, ES200945, ES200944, ES200943, ES200942, ES200940, ES200939, ES200938, ES200937, ES200936, ES200935, ES200934, ES200933, ES200932, ES200931, ES200930, ES200929, ES200928, ES200927, ES200926, ES200925, ES200924, ES200923, ES200922, ES200921, ES200920, ES200919, ES200918, ES200917, ES200916, ES200915, ES200914, ES200913, ES200912, ES200911, ES200910, ES200909, ES200908, ES200907, ES200906, ES200905, ES200904, ES200903, ES200902, ES200901, ES200900, ES200899, ES200898, ES200897, ES200896, ES200895, ES200894, ES200893, ES200892, ES200891, ES200890, ES200889, ES200888, ES200887, ES200886, ES200885, ES200884, ES200883, ES200882, ES200881, ES200880, ES200879, ES200878, ES200877, ES200876, ES200875, ES200873, ES200872, ES200871, ES200870, ES200869, ES200868, ES200867, ES200866, ES200865, ES200864, ES200863, ES200862, ES200861, ES200860, ES200859, ES200858, ES200857, ES200856, ES200854, ES200853, ES200852, ES200851, ES200850, ES200849, ES200848, ES200847, ES200846, ES200845, ES200844, ES200843, ES200842, ES200841, ES200840, ES200839, ES200838, ES200837, ES200836, ES200835, ES200834, ES200832, ES200831, ES200830, ES200829, ES200828, ES200827, ES200826, ES200825, ES200824, ES200823, ES200822, ES200821, ES200820, ES200819, ES200818, ES200817, ES200816, ES200815, ES200814, ES200813, ES200812, ES200811, ES200810, ES200809, ES200808, ES200807, ES200806, ES200805, ES200804, ES200803, ES200802, ES200801, ES200800, ES200799, ES200798, ES200797, ES200796, ES200795, ES200794, ES200793, ES200792, ES200791, ES200790, ES200788, ES200787, ES200786, ES200785, ES200784, ES200783, ES200782, ES200781, ES200780, ES200779, ES200778, ES200777, ES200776, ES200775, ES200774, ES200773, ES200772, ES200771, ES200770, ES200769, ES200768, ES200767, ES200766, ES200765, ES200764, ES200763, ES200762, ES200761, ES200760, ES200759, ES200758, ES200757, ES200756, ES200755, ES200754, ES200753, ES200752, ES200751, ES200749, ES200748, ES200747, ES200746, ES200745, ES200744, ES200743, ES200742, ES200741, ES200739, ES200738, ES200737, ES200736, ES200735, ES200734, ES200733, ES200732, ES200731, ES200730, ES200729, ES200728, ES200727, ES200726, ES200725, ES200724, ES200723, ES200722, ES200721, ES200720, ES200719, ES200718, ES200717, ES200716, ES200715, ES200714, ES200713, ES200712, ES200711, ES200710, ES200709, ES200708, ES200707, ES200706, ES200705, ES200704, ES200703, ES200702, ES200701, ES200700, ES200699, ES200698, ES200697, ES200696, ES200695, ES200694, ES200693, ES200692, ES200691, ES200690, ES200689, ES200688, ES200687, ES200686, ES200685, ES200684, ES200683, ES200682, ES200681, ES200680, ES200679, ES200678, ES200677, ES200676, ES200675, ES200674, ES200673, ES200672, ES200671, ES200670, ES200669, ES200668, ES200667, ES200666, ES200665, ES200664, ES200663, ES200662, ES200661, ES200660, ES200659, ES200658, ES200657, ES200656, ES200655, ES200654, ES200653, ES200652, ES200651, ES200650, ES200649, ES200648, ES200647, ES200646, ES200645, ES200644, ES200643, ES200642, ES200641, ES200640, ES200639, ES200638, ES200637, ES200636, ES200635, ES200634, ES200633, ES200632, ES200631, ES200630, ES200629, ES200628, ES200627, ES200626, ES200625, ES200624, ES200623, ES200621, ES200620, ES200619, ES200618, ES200617, ES200615, ES200614, ES200613, ES200612, ES200611, ES200610, ES200609, ES200608, ES200607, ES200606, ES200605, ES200604, ES200603, ES200602, ES200601, ES200600, ES200599, ES200598, ES200597, ES200596, ES200595, ES200594, ES200593, ES200592, ES200591, ES200590, ES200589, ES200588, ES200587, ES200586, ES200585, ES200584, ES200583, ES200582, ES200581, ES200580, ES200578, ES200577, ES200575, ES200574, ES200573, ES200572, ES200571, ES200570, ES200569, ES200568, ES200567, ES200566, ES200565, ES200564, ES200563, ES200562, ES200561, ES200560, ES200559, ES200558, ES200557, ES200556, ES200554, ES200553, ES200552, ES200551, ES200550, ES200549, ES200548, ES200547, ES200546, ES200545, ES200544, ES200543, ES200542, ES200541, ES200539, ES200538, ES200537, ES200536, ES200535, ES200534, ES200533, ES200532, ES200531, ES200530, ES200529, ES200528, ES200526, ES200525, ES200524, ES200523, ES200522, ES200521, ES200520, ES200519, ES200518, ES200517, ES200516, ES200515, ES200514, ES200513, ES200512, ES200511, ES200510, ES200509, ES200508, ES200507, ES200506, ES200505, ES200504, ES200503, ES200502, ES200501, ES200500, ES200499, ES200498, ES200497, ES200496, ES200495, ES200494, ES200493, ES200492, ES200491, ES200490, ES200489, ES200488, ES200487, ES200486, ES200485, ES200484, ES200483, ES200482, ES200481, ES200480, ES200479, ES200478, ES200477, ES200476, ES200475, ES200474, ES200473, ES200472, ES200470, ES200469, ES200468, ES200467, ES200466, ES200465, ES200464, ES200463, ES200462, ES200461, ES200460, ES200459, ES200458, ES200457, ES200456, ES200455, ES200454, ES200453, ES200452, ES200451, ES200450, ES200449, ES200448, ES200447, ES200446, ES200445, ES200444, ES200443, ES200442, ES200441, ES200440, ES200439, ES200438, ES200437, ES200436, ES200435, ES200434, ES200433, ES200432, ES200431, ES200430, ES200429, ES200428, ES200427, ES200426, ES200425, ES200424, ES200423, ES200422, ES200421, ES200420, ES200419, ES200418, ES200417, ES200416, ES200415, ES200414, ES200413, ES200412, ES200410, ES200409, ES200408, ES200407, ES200406, ES200405, ES200404, ES200403, ES200402, ES200401, ES200400, ES200399, ES200398, ES200397, ES200396, ES200395, ES200394, ES200393, ES200392, ES200391, ES200390, ES200389, ES200388, ES200387, ES200386, ES200385, ES200384, ES200383, ES200382, ES200381, ES200380, ES200379, ES200378, ES200377, ES200376, ES200375, ES200374, ES200373, ES200372, ES200371, ES200370, ES200369, ES200368, ES200367, ES200366, ES200364, ES200363, ES200362, ES200361, ES200360, ES200359, ES200358, ES200357, ES200356, ES200355, ES200354, ES200353, ES200352, ES200351, ES200350, ES200349, ES200348, ES200347, ES200346, ES200345, ES200344, ES200343, ES200342, ES200341, ES200340, ES200339, ES200338, ES200337, ES200336, ES200335, ES200334, ES200333, ES200332, ES200331, ES200330, ES200329, ES200328, ES200327, ES200325, ES200324, ES200323, ES200322, ES200321, ES200320, ES200319, ES200318, ES200317, ES200316, ES200315, ES200314, ES200313, ES200312, ES200311, ES200310, ES200309, ES200308, ES200307, ES200306, ES200304, ES200303, ES200302, ES200301, ES200300, ES200299, ES200298, ES200297, ES200296, ES200294, ES200293, ES200292, ES200291, ES200290, ES200289, ES200288, ES200287, ES200286, ES200285, ES200284, ES200283, ES200282, ES200281, ES200280, ES200279, ES200278, ES200277, ES200276, ES200275, ES200274, ES200273, ES200272, ES200271, ES200270, ES200269, ES200268, ES200267, ES200266, ES200265, ES200264, ES200263, ES200262, ES200261, ES200260, ES200259, ES200258, ES200257, ES200256, ES200255, ES200253, ES200252, ES200251, ES200250, ES200249, ES200248, ES200247, ES200246, ES200244, ES200243, ES200242, ES200241, ES200240, ES200239, ES200238, ES200237, ES200236, ES200235, ES200234, ES200233, ES200232, ES200231, ES200230, ES200229, ES200228, ES200227, ES200226, ES200225, ES200224, ES200223, ES200222, ES200221, ES200220, ES200219, ES200218, ES200217, ES200216, ES200215, ES200213, ES200212, ES200211, ES200210, ES200209, ES200208, ES200207, ES200206, ES200205, ES200204, ES200203, ES200202, ES200201, ES200200, ES200199, ES200198, ES200197, ES200196, ES200195, ES200194, ES200193, ES200192, ES200191, ES200190, ES200189, ES200188, ES200187, ES200186, ES200185, ES200184, ES200183, ES200182, ES200181, ES200180, ES200179, ES200178, ES200177, ES200176, ES200175, ES200174, ES200173, ES200172, ES200171, ES200169, ES200168, ES200167, ES200166, ES200165, ES200164, ES200163, ES200162, ES200161, ES200160, ES200159, ES200158, ES200157, ES200156, ES200155, ES200154, ES200153, ES200152, ES200151, ES200150, ES200149, ES200148, ES200147, ES200146, ES200145, ES200144, ES200143, ES200142, ES200141, ES200140, ES200139, ES200138, ES200137, ES200136, ES200135, ES200134, ES200133, ES200132, ES200131, ES200130, ES200129, ES200128, ES200127, ES200126, ES200125, ES200124, ES200123, ES200122, ES200121, ES200120, ES200119, ES200118, ES200117, ES200116, ES200115, ES200114, ES200113, ES200112, ES200111, ES200110, ES200109, ES200108, ES200107, ES200106, ES200105, ES200103, ES200102, ES200101, ES200100, ES200099, ES200098, ES200097, ES200096, ES200095, ES200093, ES200092, ES200091, ES200090, ES200089, ES200088, ES200087, ES200086, ES200085, ES200084, ES200083, ES200082, ES200081, ES200080, ES200079, ES200078, ES200077, ES200076, ES200075, ES200074, ES200073, ES200072, ES200071, ES200070, ES200069, ES200068, ES200067, ES200066, ES200065, ES200064, ES200063, ES200062, ES200061, ES200060, ES200059, ES200058, ES200057, ES200056, ES200055, ES200053, ES200052, ES200051, ES200050, ES200049, ES200048, ES200047, ES200046, ES200045, ES200044, ES200043, ES200042, ES200041, ES200040, ES200039, ES200038, ES200037, ES200036, ES200035, ES200034, ES200033, ES200031, ES200030, ES200029, ES200028, ES200027, ES200026, ES200025, ES200024, ES200023, ES200022, ES200021, ES200020, ES200019, ES200018, ES200017, ES200016, ES200015, ES200014, ES200013, ES200011, ES200010, ES200009, ES200008, ES200007, ES200006, ES200005, ES200003, ES200002 and ES200001.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates.
  • 제품 설명
    Excel Care ES Bariatric Bed, P 610B, Hill-Rom, Batesville, IN. || Intended use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed has an expandable surface and supports patients between 250 and 1000 pounds.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • 제조사 주소
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA