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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 100 Low Bed

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 Class 2 Recall
HillRom 100 Low Bed
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Date Posted November 18, 2009
Recall Status1 Terminated on October 15, 2010
Recall Number Z-0338-2010
Recall Event ID 51389
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
Code Information 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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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.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville, Indiana 47006
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The siderails may exhibit false latching, or unintentional lowering, or may become inoperable.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Quantity in Commerce 4017 beds
Distribution Worldwide distribution: USA, Canada, France, India, Singapore and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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