Events

Recall of HillRom 100 Low 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
    51389
  • Event Risk Class
    Class 2
  • Event Number
    Z-0338-2010
  • Event Initiated Date
    2009-04-20
  • Event Date Posted
    2009-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80169
  • 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
    AC-powered adjustable hospital bed. - Product Code FNL
  • Reason
    The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.
  • Action
    Hill Rom notified consignees by recall letter dated 4/20/09 and advised them of the problem and requested them to locate the beds. Consignees with patients in need of siderails were directed to be moved to a different model bed with siderails and, if the patient did not need siderails; consignees were requested to remove the siderails, move the siderails to a stowed position, to tie the siderail to the bed frame or to tag the siderail as out of service. The letter stated the consignee would be contacted within 90 days by a firm representative to do a correction on all affected units.

Device

HillRom 100 Low Bed
  • Model / Serial
    All units shipped prior to 3/6/09. Serial numbers  I331AR0046, I331AR0061, I331AR0062, I331AR0063, I333AR0088, I333AR0089, I333AR0090, I333AR0091, I333AR0092, I333AR0093, I333AR0094, I333AR0095, I334AR0096, I334AR0097, I334AR0098, I334AR0099, I334AR0100, I334AR0101, I334AR0102, I334AR0105, I334AR0106, I334AR0107, I334AR0108, I334AR0109, I334AR0110, I338AR0111, I338AR0112, I338AR0114, I338AR0115, I338AR0116, I338AR0118, I338AR0120, I338AR0121, I338AR0124, I338AR0125, I338AR0126, I339AR0148, I339AR0149, I339AR0150, I340AR0153, I340AR0155, I340AR0156, I340AR0157, I340AR0158, I340AR0159, I340AR0160, I340AR0161, I340AR0162, I340AR0163, I340AR0165, I340AR0166, I340AR0167, I340AR0168, I340AR0171, I348AR0177, I349AR0177, I349AR0179, I349AR0180, I349AR0181, I349AR0182, I349AR0183, I349AR0184, I349AR0185, I349AR0186, I349AR0187, I349AR0188, I349AR0189, I349AR0190, I349AR0191, I349AR0192, I349AR0193, I351AR0199, I351AR0200, I351AR0201, I351AR0202, I351AR0203, I351AR0204, I351AR0205, I351AR0206, I351AR0207, I351AR0208, I351AR0209, 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K071AR6300, K071AR6301, K071AR6302, K072AR6309, K072AR6310, K072AR6313, K072AR6314, K072AR6315, K072AR6316, K072AR6317, K072AR6318, K072AR6319, K075AR6320, K075AR6321, K075AR6322, K075AR6323, K075AR6324, K075AR6325, K075AR6326, K075AR6327, K075AR6328, K075AR6329, K075AR6330, K075AR6331, K075AR6332, K075AR6333, K075AR6334, K075AR6335, K075AR6336, K075AR6337, K076AR6338, K076AR6355, K076AR6356, K076AR6367, K078AR6375, K078AR6376, K078AR6377, K078AR6378, K078AR6379, K078AR6380, K078AR6381, K078AR6382, K078AR6383, K078AR6384, K078AR6385, K079AR6386, K079AR6387, K079AR6388, K079AR6389, K079AR6390, K079AR6391, K079AR6392, K079AR6393, K079AR6394, K079AR6395, K079AR6396, K079AR6397, K079AR6398, K079AR6399, K079AR6400, K082AR6402, K082AR6403, K082AR6406, K082AR6407, K082AR6408, K082AR6409, K082AR6410, K082AR6411, K082AR6412, K082AR6413, K082AR6414, K082AR6415, K083AR6416, K083AR6417, K083AR6418, K083AR6419, K083AR6420, K083AR6421, K083AR6422, K083AR6423, K083AR6424, K084AR6439, K084AR6440, K084AR6441, K084AR6442, K084AR6443, K084AR6444, K084AR6446, K084AR6447, K085AR6448, K085AR6449, K085AR6450, K085AR6451, K085AR6452, K085AR6453, K085AR6454, K085AR6455, K085AR6456, K085AR6457, K085AR6458, K085AR6459, K085AR6460, K085AR6461, K085AR6462, K085AR6463, K085AR6464, K086AR6465, K086AR6466, K086AR6467, K086AR6468, K086AR6469, K086AR6470, K086AR6471, K086AR6472, K086AR6473, K086AR6474, K086AR6476, K096AR6481, K096AR6482, K096AR6484, K096AR6485, K096AR6486, K096AR6487, K096AR6488, K096AR6489, K096AR6490, K096AR6491, K096AR6492, K096AR6493, K096AR6494, K097AR6495, K097AR6496, K097AR6497, K097AR6498, K097AR6499, K097AR6500, K097AR6502, K097AR6503, K097AR6504, K097AR6505, K097AR6506, K097AR6507, K097AR6508, K097AR6509, K097AR6510, K098AR6511, K098AR6512, K098AR6513, K098AR6514, K098AR6515, K098AR6516, K098AR6517, K098AR6518, K098AR6519, K098AR6520, K098AR6527, K098AR6528, K098AR6529, K098AR6530, K098AR6531, K099AR6532, K099AR6533, K099AR6534, K099AR6535, K099AR6536, K099AR6537, K099AR6538, K099AR6539, K099AR6540, K099AR6541, K099AR6543, K099AR6544, K110AR6545, K110AR6546, K110AR6547, K110AR6548, K110AR6549, K110AR6550, K110AR6551, K110AR6552, K110AR6553, K110AR6554, K110AR6555, K110AR6556, K110AR6557, K110AR6561, K110AR6562, K110AR6563, K111AR6564, K111AR6565, K111AR6566, K111AR6567, K111AR6568, K111AR6569, K111AR6570, K111AR6571, K111AR6572, K111AR6573, K111AR6574, K111AR6575, K111AR6576, K111AR6577, K111AR6578, K111AR6579, K112AR6580, K112AR6581, K112AR6582, K112AR6583, K112AR6584, K112AR6585, K112AR6586, K112AR6587, K112AR6588, K112AR6589, K112AR6590, K112AR6591, K112AR6592, K112AR6593, K112AR6594, K112AR6595, K113AR6596, K113AR6597, K113AR6598, K113AR6599, K113AR6600, K113AR6601, K113AR6602, K113AR6603, K113AR6604, K113AR6605, K113AR6606, K113AR6607, K113AR6608, K113AR6609, K114AR6610, K114AR6611, K114AR6612, K114AR6613, K114AR6614, K114AR6615, K114AR6616, K114AR6617, K114AR6618, K114AR6619, K114AR6620, K114AR6621, K114AR6622, K114AR6623, K114AR6624, K114AR6625, K124AR6626, K124AR6627, K124AR6628, K124AR6629, K124AR6630, K124AR6631, K124AR6632, K124AR6633, K124AR6634, K124AR6635, K124AR6637, K124AR6638, K124AR6639, K124AR6640, K124AR6641, K124AR6642, K124AR6643, K125AR6644, K125AR6647, K125AR6648, K125AR6649, K125AR6650, K125AR6651, K125AR6652, K125AR6653, K125AR6654, K125AR6655, K125AR6656, K125AR6657, K125AR6658, K125AR6659, K125AR6660, K125AR6661, K125AR6662, K125AR6663, K126AR6664, K126AR6665, K126AR6666, K126AR6667, K126AR6668, K126AR6669, K126AR6670, K126AR6671, K126AR6672, K126AR6673, K126AR6674, K126AR6675, K126AR6676, K126AR6677, K126AR6678, K127AR6679, K127AR6680, K127AR6681, K127AR6682, K127AR6683, K127AR6684, K127AR6685, K127AR6686, K127AR6687, K127AR6688, K127AR6689, K127AR6690, K127AR6691, K127AR6692, K127AR6694, K127AR6695, K127AR6696, K131AR6697, K131AR6698, K131AR6699, K131AR6700, K131AR6701, K131AR6702, K131AR6703, K131AR6704, K131AR6705, K131AR6706, K131AR6708, K131AR6709, K131AR6710, K131AR6711, K131AR6712, K131AR6713, K131AR6714, K131AR6715, K131AR6716, K131AR6717, K131AR6718, K131AR6719, K131AR6720, K131AR6721, K131AR6722, K132AR6723, K132AR6724, K132AR6725, K132AR6726, K132AR6727, K132AR6728, K132AR6729, K132AR6730, K132AR6731, K132AR6732, K132AR6733, K132AR6734, K132AR6735, K132AR6736, K132AR6737, K132AR6738, K132AR6739, K132AR6740, K132AR6741, K132AR6742, K133AR6743, K133AR6744, K133AR6745, K133AR6746, K133AR6747, K133AR6748, K133AR6749, K133AR6750, K133AR6751, K133AR6752, K133AR6753, K133AR6754, K133AR6755, K133AR6756, K133AR6757, K133AR6758, K133AR6759, K133AR6760, K133AR6761, K134AR6763, K134AR6764, K134AR6765, K134AR6766, K134AR6767, K134AR6769, K134AR6771, K134AR6772, K135AR6778, K135AR6781, K135AR6782, K135AR6783, K135AR6786, K135AR6787, K135AR6790, K135AR6795, K135AR6796, K135AR6797, K138AR6798, K138AR6799, K138AR6800, K138AR6801, K138AR6802, K138AR6804, K138AR6805, K138AR6808, K138AR6809, K138AR6810, K138AR6811, K138AR6812, K138AR6813, K138AR6814, K138AR6815, K138AR6816, K138AR6817, K138AR6818, K139AR6819, K139AR6820, K139AR6821, K139AR6822, K139AR6823, K139AR6826, K139AR6827, K139AR6828, K139AR6829, K139AR6830, K139AR6831, K139AR6832, K139AR6833, K139AR6834, K139AR6835, K139AR6836, K139AR6837, K139AR6838, K139AR6839, K139AR6840, K139AR6841, K139AR6842, K139AR6843, K139AR6844, K139AR6845, K139AR6846, K140AR6847, K140AR6848, K140AR6849, K169AR6891, K169AR6892 and K169AR6893.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, France, India, Singapore and Spain.
  • Product Description
    Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
  • 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