Events

Recall of HillRom Basic Care 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
    56018
  • Event Risk Class
    Class 2
  • Event Number
    Z-2169-2010
  • Event Initiated Date
    2009-09-16
  • Event Date Posted
    2010-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92433
  • 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
    The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin e-ring, which could cause the e-ring to come off.
  • Action
    The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support.

Device

HillRom Basic Care Bed
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.
  • Product Description
    Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN. || Intended for low to moderate acuity patients in the low end acute care area of the hospital.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA