Events

Recall of Device Recall HillRom 70 SemiElectric 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
    50181
  • Event Risk Class
    Class 2
  • Event Number
    Z-0506-2009
  • Event Initiated Date
    2008-11-11
  • Event Date Posted
    2009-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74910
  • 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
    AC-Powered Adjustable Hospital Bed - Product Code FNL
  • Reason
    Failure, mechanical: if the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. for further information, please contact hill-rom, inc. at 800-445-3720.
  • Action
    Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction."

Device

Device Recall HillRom 70 SemiElectric Bed
  • Model / Serial
    Serial numbers HC100001 through HC101261.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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