Events

Recall of Device Recall Excel Care ES Bariatric Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, Inc..

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
    55301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0333-2011
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90507
  • 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
    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.
  • Action
    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
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA