Events

Recall of Device Recall TotalCare AC powered adjustable hospital bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57733
  • Event Risk Class
    Class 2
  • Event Number
    Z-1221-2011
  • Event Initiated Date
    2011-02-03
  • Event Date Posted
    2011-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97268
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 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.
  • 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.

Device

Device Recall TotalCare AC powered adjustable hospital bed
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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).
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA