Z-1563-2011

TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed...

Name: Z-1563-2011 TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed...
Creator: Hill-Rom, Inc.
Published: 2011-02-21
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2011-02-21 / Terminated / root cause: supplier

FDA source

Hill-Rom, Inc. began a recall of TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support... on 2011-02-21. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1563-2011
Status: Terminated
Initiated: 2011-02-21
Posted: 2011-03-07
Terminated: 2012-08-06
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
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 experie
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: 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
Product codes and lots: 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.

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)