Recall of Device Recall TotalCare bed system

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
  • Reason
    A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.
  • Action
    A letter dated 3/15/04 was sent to each affected consignee, with labels included, requesting that they attach them to each affected bed.


  • Model / Serial
    All remanufactured beds distributed between August 2003 and February 2004.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Arizona, Florida, Georgia, Nevada, Puerto Rico, Texas, Virginia and Canada.
  • Product Description
    Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only.
  • Manufacturer


  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, Batesville IN 47006
  • Source