Hill-Rom, Inc.: TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution

Recall number

Z-1563-2011

Recalling firm

Hill-Rom, Inc.

Product

TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution

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 experie

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

116

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

J212AM8818, K202AM4400, L196AM9109, L200AM9139, L200AM9142, L200AM9145, L200AM9148, L209AM9299, L209AM9302, L209AM9314, L217AM9487, L218AM9499, L218AM9502, L218AM9524, L221AM9579, L222AM9584, L222AM9588, L222AM9596, L222AM9601, L222AM9610, L223AM9611, L223AM9614, L223AM9617, L223AM9620, L223AM9624, L223AM9630, L224AM9647, L224AM9650, L224AM9653, L224AM9656, L224AM9662, L225AM9666, L225AM9680, L225AM9684, L225AM9689, L226AM9693, L226AM9697, L226AM9700, L228AM9716, L228AM9720, L228AM9724, L228AM9728, L228AM9732, L231AM9812, L235AM9942, L235AM9945, L235AM9948, L235AM9952, L235AM9957, L236AM9960, L236AM9983, L236AM9988, L236AM9995, L237AM0026, L237AM0030, L250AM0297, L250AM0303, L250AM0306, L250AM0309, L250AM0312, L250AM0324, L250AM0327, L250AM0330, L251AM0333, L251AM0337, L251AM0342, L251AM0345, L251AM0348, L251AM0351, L251AM0354, L251AM0357, L251AM0361, L252AM0370, L252AM0377, L252AM0402, L256AM0522, L257AM0541, L257AM0548, L258AM0566, L258AM0570, L258AM0576, L258AM0596, L258AM0603, L270AM0920, L271AM0923, L271AM0928, L271AM0931, L271AM0932, L271AM0936, L271AM0939, L272AM0954, L273AM0971, L273AM0973, L273AM0979, L273AM0981, L274AM1000, L285AM1143, L286AM1140, L286AM1163, L287AM1184, L288AM1206, L291AM1235, L301AM1396, L301AM1400, L301AM1403, L302AM1423, L306AM1473, L306AM1476, L307AM1479, L307AM1482, L323AM1757 and L326AM1762.

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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