Hill-Rom, Inc.: Hill-Rom TotalCare Bariatric Bed, P1840, 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).

Recall number

Z-1221-2011

Recalling firm

Hill-Rom, Inc.

Product

Hill-Rom TotalCare Bariatric Bed, P1840, 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).

Status

Terminated

Initiated

2011-02-03

Posted

2011-02-11

Terminated

2012-09-26

Reason

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.

Root 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

40 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.

Lot, serial or model codes

J106AM7237, J107AM7243, J107AM7249, J115AM7361, J115AM7365, J115AM7368, J084AM6731, J084AM6737, J085AM6756, J085AM6760, J084AM6723, J095AM7019, J098AM7041, J084AM6747, J086AM6812, J114AM7341, J156AM7992, J085AM6757, J086AM6792, J086AM6796, J086AM6806, J086AM6806, J091AM6906, J091AM6919, J095AM7014, J101AM7145, J114AM7342, J116AM7391, J119AM7400, J130AM7605, J148AM7842, J148AM7844, J148AM7848, J162AM8078, J163AM8107, J113AM7335, J113AM7336, J127AM7535, J127AM7542 and J133AM7621.

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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