HILL-ROM MANUFACTURING, INC.

Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·June 19, 2008

Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·December 6, 2010

Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·December 6, 2010

Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.

FDA Enforcement

Class II ·Terminated·HILL-ROM MANUFACTURING, INC.·December 6, 2017

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

FDA Enforcement

Class II ·Terminated·Hill-Rom Manufacturing, Inc.·December 2, 2020

Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.

FDA Recall

Terminated ·HILL-ROM MANUFACTURING, INC.·Product code BYI·September 15, 2017

Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

Clinitron At Home Air Fluidized Therapy Unit

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code INX·January 14, 2002

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.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

CLINITRON UP-LIFT Air Fluidized Therapy unit.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code INX·May 5, 2003

CLINITRON CII Air Fluidized Therapy unit.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code INX·May 5, 2003

Clinitron At Home Air Fluidized Therapy Bed

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNL·May 20, 2005

FLEXICAIR MC3 Low Airloss Therapy unit

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

Magnum II Bariatric Patient Care System

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNL·March 4, 2004

Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code INX·June 24, 2009

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

FDA Recall

Terminated ·Hill-Rom Manufacturing, Inc.·Product code CBK·November 12, 2020