Class 2 Device Recall Total Care bed

• Date Initiated by Firm: February 21, 2011
• Date Posted: March 07, 2011
• Recall Status: Terminated on August 06, 2012
• Recall Number: Z-1563-2011
• Recall Event ID: 57944
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; 1069 State Route 46 East; Batesville IN 47006
• For Additional Information Contact: 812-934-7777
• Manufacturer 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
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.