Events

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
    Recall
  • Event ID
    28465
  • Event Risk Class
    Class 2
  • Event Number
    Z-0761-04
  • Event Initiated Date
    2004-03-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31955
  • 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.

Device

Device Recall TotalCare bed system
  • Model / Serial
    All remanufactured beds distributed between August 2003 and February 2004.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arizona, Florida, Georgia, Nevada, Puerto Rico, Texas, Virginia and Canada.
  • Product Description
    Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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