Events

Recall of HillRom

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
    25899
  • Event Risk Class
    Class 2
  • Event Number
    Z-0902-03
  • Event Initiated Date
    2003-04-24
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26689
  • 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
    Table, Obstetric (And Accessories) - Product Code KNC
  • Reason
    Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
  • Action
    Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]

Device

HillRom
  • Model / Serial
    All units distributed between January 1, 1999 and July 1, 2002.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Bahamas, Bermuda, Canada, Colombia, Costa Rica, Dominican Republic, Guam, Japan, Mexico, Panama, Saudi Arabia, South Korea, Taiwan and Venezuela
  • Product Description
    Hill-Rom brand Century+ series bed
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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