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
    52032
  • Event Risk Class
    Class 2
  • Event Number
    Z-1874-2009
  • Event Initiated Date
    2009-05-12
  • Event Date Posted
    2009-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81938
  • 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
    air therapy mattress - Product Code IOQ
  • Reason
    The devices may emit smoke from the blower box assembly.
  • Action
    Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair¿ II and Flexicair¿ MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair¿ MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.

Device

Device Recall Flexicair II
  • Model / Serial
    All serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where "xxxxxx" is a six digit number. The prefix "IB" is representative of a Flexicair¿ II.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Flexicair¿ II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA