Events

Recall of Device Recall Clinitron Rite Hite Bed headboard and foot side rails.

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
    60888
  • Event Risk Class
    Class 3
  • Event Number
    Z-1132-2012
  • Event Initiated Date
    2012-02-03
  • Event Date Posted
    2012-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106718
  • 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, air fluidized - Product Code INX
  • Reason
    The firm identified in october 2011 that the clinitron rite hite bed and clinitron at home bed headboards failed to meet the safety standard force requirements. the firm identified in october 2011 that the clinitron rite hite bed and clinitron at home bed outer rail, which is extruded aluminum tubing, is intended to be one piece joined together by a weld at the lower center. the parts receiv.
  • Action
    Hill-Rom, Inc. sent a Modification Notice Urgent Medical Device Correction Notification dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The modification notice instructed all customers to find and replace all headboards and food side rails that do not meet design intent. All technicians will inspect all affected product in the service centers and all at home and rite hite beds for an "x" or "L" stamp. The technicians will inspect the beds that are still in use during scheduled maintenance or before each rental. All will be completed before 01-JUL-12. For support call 1-800-445-3720

Device

Device Recall Clinitron Rite Hite Bed headboard and foot side rails.
  • Model / Serial
    The headboard (p/n 6020200003) and siderail (p/n 6020200002) are not serialized. There are no model, catalog or code number identification marks available on the accessories. It is possible to identify these accessories though by a mark stamped into the mounting post that are used to attach these accessories to the bed. May 2011 and October 2011 headboards and siderails were shipped to customers.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY. and the country of Canada.
  • Product Description
    Clinitron Rite Hite Bed headboard and foot side rails. || The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA