Events

Recall of Device Recall FLEXICAIR II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Manufacturing, 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
    27202
  • Event Risk Class
    Class 2
  • Event Number
    Z-0058-04
  • Event Initiated Date
    2003-08-27
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29417
  • 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, Flotation Therapy, Powered - Product Code IOQ
  • Reason
    Reports of patient entrapment between mattress and side-rails.
  • Action
    Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.

Device

Device Recall FLEXICAIR II
  • Model / Serial
    Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
  • Product Description
    FLEXICAIR¿ II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Road, Charleston SC 29405
  • Source
    USFDA