510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-1564-2011

VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The...

Hill-Rom Inc. / initiated 2011-02-21 / Terminated / root cause: supplier
FDA source (opens on fda.gov)

Hill-Rom, Inc. began a recall of VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The VersaCare Bed System is intended to provide a patient... on . The reason FDA records is "Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade...". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-1564-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experi
Root cause tag
supplier
FDA root cause
Other
Action
Hill-Rom sent an "IMPORTANT MEDICAL DEVICE CORRECTION" notice dated February 21, 2011, to Facility Risk Manager/Facility Administrators. The letter states that because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate.This issue does not pose a hazard to patients as long as normal patient monitoring is in effect in relation to managing skin temperature and moisture. Customers were instructed to continue to use the product as they normally would. The mattress system would provide an alarm in the event the MCM blower does not operate properly. A Hill-Rom representative would be contacting their facility to make arrangements for correcting the affected MCM blowers. If customers had any questions concerning this request or the procedure as outlined, they were instructed to contact Hill-Rom Technical Support at 800-445-3720. For questions regarding this recall call 812-934-7777.
Quantity in commerce
1609
Distribution
Worldwide Distribution - USA including AL, CA, CO, CT, DC, DE, FL, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WI, and the countries of ARUBA, AUSTRIA, CANADA, FRANCE, GERMANY, LEBANON, PORTUGAL and SAUDI ARABIA
Product codes and lots
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L315AD7600, L315AD7602, L315AD7603, L315AD7604, L315AD7606, L315AD7607, L315AD7609, L315AD7610, L315AD7611, L315AD7614, L315AD7618, L316AD7667, L316AD7670, L316AD7673, L319AD7730, L319AD7732, L319AD7734, L319AD7736, L319AD7738, L319AD7740, L319AD7742, L319AD7744, L322AD8012, L322AD8014, L322AD8016, L322AD8018, L322AD8022, L322AD8032, L323AD8096, L323AD8098, L323AD8102, L323AD8104, L323AD8106, L323AD8108, L323AD8110, L323AD8111, L323AD8113, L323AD8116, L326AD8121, L326AD8123, L326AD8125, L326AD8128, L326AD8133, L326AD8135, L326AD8138, L326AD8152, L326AD8157, L326AD8162, L326AD8176, L326AD8181, L326AD8183, L327AD8187, L327AD8192, L327AD8197, L327AD8235, L327AD8241, L327AD8246, L328AD8251, L328AD8256, L328AD8261, L328AD8266, L328AD8271, L328AD8276, L328AD8305, L328AD8310, L328AD8317, L333AD8336, L333AD8341, L333AD8346, L333AD8351, L333AD8356, L333AD8361, L334AD8415, L335AD8481, L335AD8484, L335AD8487, L335AD8544, L335AD8545, L336AD8547, L336AD8548, L336AD8550, L336AD8552, L336AD8554, L342AD9053, L342AD9060, L342AD9071, L342AD9073, L342AD9087, L342AD9091, L343AD9175, L343AD9178, L343AD9181, L343AD9184, L343AD9191, L343AD9194, L343AD9197, L343AD9200, L343AD9203, L343AD9208, L343AD9211, L343AD9214, L343AD9217, L343AD9221, L343AD9222, L343AD9227, L343AD9233, L343AD9253, L344AD9340, L344AD9346, L344AD9395, L345AD9536, L345AD9539, L345AD9542, L345AD9545, L345AD9548, L345AD9551, L345AD9554, L345AD9557, L345AD9560, L345AD9566, L345AD9570, L345AD9573, L345AD9578, L345AD9579, L345AD9583, L345AD9595, L345AD9598, L345AD9601, L345AD9608, L345AD9614, L345AD9616, L345AD9618, L347AD9641, L347AD9646, L347AD9654, L347AD9656, L347AD9658, L347AD9660, L347AD9662, L347AD9668, L347AD9672, L347AD9676, L347AD9680, L347AD9682, L347AD9686, L347AD9688, L347AD9691, L347AD9695, L347AD9699, L347AD9701, L347AD9703, L347AD9705, L347AD9707, L347AD9709, L348AD9712, L348AD9713, L348AD9719, L348AD9751, L348AD9753, L348AD9755, L348AD9757, L348AD9759, L348AD9761, L348AD9763, L348AD9765, L348AD9767, L348AD9769, L349AD9862, L349AD9864, L349AD9867, L349AD9868, L349AD9869, L349AD9871, L349AD9873, L349AD9875, L350AD9877, L350AD9879, L350AD9881, L350AD9883, L350AD9885, L350AD9887, L350AD9889, L350AD9891, L350AD9893, L350AD9895, L350AD9897, L350AD9899, L350AD9901, L350AD9903, L350AD9905, L350AD9907, L350AD9909, L350AD9911, L350AD9913, L350AD9915, L350AD9917, L350AD9919, L350AD9922, L350AD9924, L350AD9926, L350AD9928, L350AD9930, L350AD9931, L350AD9932, L350AD9934, L350AD9935, L350AD9937, L350AD9938, L350AD9939, L350AD9941, L350AD9942, L350AD9944, L350AD9946, L350AD9948, L350AD9950, L350AD9952, L350AD9954, L350AD9955, L350AD9956, L350AD9958, L350AD9959, L350AD9960, L351AD0000, L351AD0003, L351AD0007, L351AD9962, L351AD9963, L351AD9964, L351AD9966, L351AD9967, L351AD9968, L351AD9970, L351AD9971, L351AD9972, L351AD9974, L351AD9975, L351AD9976, L351AD9978, L351AD9979, L351AD9980, L351AD9982, L351AD9983, L351AD9984, L351AD9986, L351AD9987, L351AD9988, L351AD9990, L351AD9991, L351AD9993, L351AD9996, L355AD0209, L355AD0211, L355AD0213, L355AD0215, L355AD0217, L355AD0219, L356AD0222, L356AD0224, L356AD0226, L356AD0228, L356AD0249, L356AD0251, L356AD0252, L356AD0254, L357AD0333, L357AD0342, L357AD0344, L357AD0347, L357AD0351, L357AD0352, L357AD0355, L357AD0356, L357AD0358, L357AD0367, L357AD0369, L357AD0370, M003AD0384, M003AD0387, M003AD0390, M003AD0393, M003AD0396, M003AD0399, M003AD0405, M003AD0408, M003AD0411, M003AD0412, M003AD0415, M003AD0433, M003AD0435, M004AD0468, M004AD0469, M004AD0481, M005AD0543, M005AD0545, M005AD0547, M005AD0550, M005AD0554, M005AD0558, M005AD0560, M005AD0562, M005AD0564, M005AD0565, M005AD0566, M005AD0568, M005AD0570, M005AD0572, M005AD0574, M006AD0615, M006AD0621, M006AD0622, M006AD0623, M006AD0625, M006AD0627, M006AD0631, M006AD0632, M006AD0634, M006AD0637, M006AD0638, M006AD0656, M006AD0660, M006AD0668, M006AD0670, M006AD0672, M006AD0673, M006AD0676, M006AD0679, M006AD0682, M006AD0685, M006AD0694, M006AD0698, M006AD0702, M006AD0709, M006AD0713, M007AD0718, M007AD0719, M007AD0723, M007AD0740, M007AD0741, M007AD0749, M007AD0750, M007AD0753, M007AD0762, M007AD0763, M007AD0766, M007AD0767, M007AD0769, M007AD0770, M007AD0771, M007AD0778, M007AD0780, M010AD0790, M010AD0793, M010AD0796, M010AD0800, M010AD0801, M010AD0802, M010AD0805, M010AD0808, M010AD0821, M010AD0824, M010AD0828, M011AD0884, M011AD0904, M011AD0907, M011AD0908, M011AD0911, M011AD0913, M011AD0915, M011AD0916, M011AD0918, M011AD0922, M011AD0924, M011AD0926, M011AD0928, M011AD0930, M011AD0932, M011AD0935, M011AD0937, M011AD0940, M011AD0944, M011AD0946, M011AD0948, M011AD0950, M011AD0951, M012AD0959, M012AD0960, M012AD0963, M012AD0964, M012AD0967, M012AD0969, M012AD0973, M012AD0975, M012AD0976, M012AD0977, M012AD0979, M012AD0980, M012AD0982, M012AD0983, M012AD0985, M012AD0990, M012AD0993, M012AD0998, M012AD0999, M012AD1000, M012AD1001, M012AD1002, M012AD1003, M012AD1004, M012AD1005, M012AD1006, M012AD1007, M012AD1008, M012AD1009, M012AD1010, M012AD1011, M012AD1012, M012AD1013, M012AD1014, M012AD1015, M012AD1016, M012AD1017, M012AD1019, M012AD1021, M013AD1024, M013AD1025, M013AD1027, M013AD1029, M013AD1030, M013AD1033, M013AD1035, M013AD1037, M013AD1039, M013AD1043, M013AD1044, M013AD1045, M013AD1047, M013AD1048, M013AD1050, M013AD1051, M013AD1052, M013AD1054, M013AD1055, M013AD1060, M013AD1062, M013AD1064, M013AD1070, M013AD1072, M013AD1073, M013AD1074, M013AD1076, M013AD1077, M013AD1078, M013AD1080, M013AD1081, M013AD1083, M013AD1084, M013AD1086, M013AD1087, M013AD1088, M013AD1109, M017AD1298, M017AD1299, M017AD1300, M017AD1301, M017AD1302, M017AD1303, M018AD1310, M018AD1311, M018AD1312, M018AD1313, M018AD1317, M018AD1321, M018AD1325, M018AD1331, M018AD1334, M018AD1336, M018AD1343, M018AD1349, M018AD1369, M019AD1397, M019AD1470, M019AD1471, M020AD1482, M020AD1484, M020AD1488, M020AD1489, M020AD1491, M020AD1493, M020AD1495, M020AD1498, M020AD1501, M020AD1502, M020AD1504, M020AD1508, M020AD1509, M020AD1510, M020AD1512, M020AD1513, M020AD1515, M020AD1516, M020AD1517, M020AD1521, M020AD1522, M020AD1523, M020AD1525, M020AD1528, M020AD1530, M020AD1532, M020AD1534, M027AD1921, M028AD3004, M028AD3005, M029AD3084, M029AD3092, M029AD3096, M029AD3098, M029AD3100, M029AD3102, M031AD3156, M031AD3159, M031AD3162, M031AD3166, M031AD3172, M031AD3175, M034AD3206, M034AD3238, M034AD3240, M034AD3244, M034AD3246, M035AD3291 and M035AD3305.