Events

Recall of Device Recall HillRom TotalCare 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
    51562
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-2009
  • Event Initiated Date
    2009-03-09
  • Event Date Posted
    2009-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80702
  • 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
    An e-ring may not have been installed during production, which could result in an inability to latch the siderail.
  • Action
    Consignees were notified by an Urgent Medical Device Correction letter dated 3/9/09 and were instructed that a Hill-Rom technician will visit each consignee to inspect and to correct the beds, if necessary. The firm asks that consignees locate and test their beds to make sure the siderails are latching correctly; forward a copy of the letter to users that were loaned or purchased the device and notify Hill-Rom of their new locations or owners; and if affected beds were disposed of or are no longer in use, to inform the firm of their serial numbers. If there are questions customers should contact their Hill-Rom Technical Support for their geographic region.

Device

Device Recall HillRom TotalCare Bed
  • Model / Serial
    Serial numbers from J329AM1149 through J339AM1343.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Hill-Rom TotalCare Bed, Model P1900. || The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post
  • 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