Class 2 Device Recall TotalCare AC powered adjustable hospital bed

• Date Initiated by Firm: February 03, 2011
• Date Posted: February 11, 2011
• Recall Status: Terminated on September 26, 2012
• Recall Number: Z-1220-2011
• Recall Event ID: 57733
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. ; ; TheTotalCare Bed System is intended to porvide 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).
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• 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: The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.
• FDA Determined Cause: Software design
• Action: The firm, Hill-Rom, sent a "URGENT MEDICAL DEVICE CORRECTION" letter dated January 19, 2011, along with a software upgrade (USB stick/flash drive) with instructions, to all affected customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to requests that facility service personnel immediately upgrade their software; complete and return the Customer Response Form via fax to 812-931-2410 or mail to: Hill-Rom Company, 1069 State Route 46 E, Batesville, IN 47006, Attn: MOD Coordinator J12 and forward a copy of this notice to any other facility personnel. Note: The customer can request that Hill-Rom technicians complete the software upgrade. If you have any questions concerning this Urgent Medical Device Correction, please contact Hill-Rom Technical Support at 800-445-3720.
• Quantity in Commerce: 905 beds.
• Distribution: Worldwide distribution: USA and countries including: AUSTRALIA, BRAZIL, CANADA, CHINA, EGYPT, GERMANY, GREECE, ITALY, JAPAN, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, OMAN, POLAND, QATAR, SAUDI ARABIA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, VENEZUELA, and YEMEN.
• 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.