Hill-Rom, Inc.: 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).

Recall number

Z-1564-2011

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).

Status

Terminated

Initiated

2011-02-21

Posted

2011-03-07

Terminated

2012-08-06

Reason

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

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

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

Lot, serial or model codes

K356AD0067, K356AD0071, K356AD0107, K356AD0108, L005AD0273, L088AD4924, L089AD5029, L089AD5045, L089AD5047, L131AD6851, L132AD6912, L138AD7208, L138AD7209, L138AD7211, L138AD7212, L138AD7214, L138AD7215, L138AD7217, L138AD7218, L138AD7238, L138AD7239, L144AD7506, L145AD7520, L145AD7522, L145AD7525, L145AD7528, L145AD7531, L145AD7533, L145AD7543, L145AD7549, L145AD7552, L158AD8221, L176AD9387, L176AD9399, L182AD9683, L182AD9695, L182AD9696, L182AD9704, L182AD9714, L182AD9724, L182AD9728, L183AD9733, L183AD9734, L183AD9735, L183AD9738, L183AD9739, L183AD9742, L183AD9743, L183AD9744, L183AD9753, L183AD9786, L183AD9793, L183AD9800, L193AD9807, L193AD9809, L193AD9811, L193AD9813, L193AD9815, L193AD9817, L193AD9819, L193AD9820, L193AD9824, L193AD9826, L193AD9830, L193AD9835, L193AD9840, L193AD9843, L193AD9847, L193AD9852, L193AD9855, L194AD9876, L194AD9886, L194AD9889, L194AD9891, L194AD9895, L194AD9898, L194AD9902, L194AD9908, L194AD9910, L195AD9933, L195AD9940, L196AD0034, L200AD0169, 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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, 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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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

1824206

Firm city

Batesville

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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