Events

Recall of Device Recall Century

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
    32108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0948-05
  • Event Initiated Date
    2005-05-20
  • Event Date Posted
    2005-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39146
  • 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
    Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side.
  • Action
    Consignees were notified via letter dated 5/20/05 that the firm will visit consignees to make corrections to the beds.

Device

Device Recall Century
  • Model / Serial
    Beds built between March 2005 and May 2005.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (California, District of Columbia, Florida, Massachusetts, Montana, Nevada, New Jersey, New York, Pennsylvania, Texas, Virginia), Brazil and Canada.
  • Product Description
    Hill-Rom Century+ Bed, Model P1400.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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