Events

Recall of Device Recall Century 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
    28009
  • Event Risk Class
    Class 2
  • Event Number
    Z-0338-04
  • Event Initiated Date
    2003-12-26
  • Event Date Posted
    2004-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31018
  • 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
    If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input.
  • Action
    A recall letter dated December 26, 2003 was sent to each customer. Customers are asked to follow instructions in the user manual, if there is a fluid spill onto a unit, until Hill-Rom can inspect each unit to determine whether it is affected by the problem.

Device

Device Recall Century bed
  • Model / Serial
    All beds distributed between August 3, 2003 and August 20, 2003.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Canada , Panama and Taiwan.
  • Product Description
    Hill-Rom brand 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