Hill-Rom Manufacturing, Inc.
Saint Paul, MN, US
HILL-ROM MANUFACTURING, INC. appears in FDA device records in Saint Paul, MN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Hill-Rom Manufacturing, Inc. between 2002 and 2008. The busiest year on record is 2003, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080226 | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 | HGM | Substantially Equivalent | |
| K032772 | MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM | HGM | Substantially Equivalent | |
| K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E | FMZ | Substantially Equivalent | |
| K014094 | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM | HGM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183816 | 2183816 | HILL-ROM MANUFACTURING, INC. | 1020 COUNTY ROAD F W, SAINT PAUL, MN 55126 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0484-2021 | 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. | Under certain conditions, there is a risk for fire. | Class II | Terminated | |
| Z-0192-2018 | 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. | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device. | Class II | Terminated | |
| Z-1254-2011 | 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. | Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. | Terminated | ||
| Z-1253-2011 | 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. | Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used. | Terminated | ||
| Z-1903-2009 | CLINITRON UP-LIFT" 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. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. | Terminated | ||
| Z-1902-2009 | 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. | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. | Terminated | ||
| Z-1875-2009 | Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores. | The devices may emit smoke from the blower box assembly. | Terminated | ||
| Z-1874-2009 | Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. | The devices may emit smoke from the blower box assembly. | Terminated | ||
| Z-0603-2009 | Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies. | These devices have the potential to overheat. | Terminated | ||
| Z-0602-2009 | 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. | These devices have the potential to overheat. | Terminated | ||
| Z-0601-2009 | 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. | These devices have the potential to overheat. | Terminated | ||
| Z-0600-2009 | Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy. | These devices have the potential to overheat. | Terminated | ||
| Z-0088-2009 | 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. | A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly. | Terminated | ||
| Z-1555-05 | Clinitron At Home Air Fluidized Therapy Bed | Sudden unexpected lowering of the head of the bed may occur due to failure of the had of the bed actuator. | Terminated | ||
| Z-0810-04 | Magnum II Bariatric Patient Care System | Bed may pose a health hazard due to: A) Inability to articulate the frame during transport, B) Exposed sharp edge of footplate, C) Shear point between seat section and lymph panel and D) Patient fall. | Terminated | ||
| Z-0059-04 | FLEXICAIR MC3 Low Airloss Therapy unit | Reports of patient entrapment between mattress and side-rails. | Terminated | ||
| Z-0058-04 | 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. | Reports of patient entrapment between mattress and side-rails. | Terminated | ||
| Z-0990-03 | CLINITRON UP-LIFT Air Fluidized Therapy unit. | Malfunction of side-rail latching pin coupled with inadequate directions for use. | Terminated | ||
| Z-0989-03 | CLINITRON CII Air Fluidized Therapy unit. | Malfunction of side-rail latching pin coupled with inadequate directions for use. | Terminated | ||
| Z-0057-04 | Clinitron At Home Air Fluidized Therapy Unit | Power cord overheating | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain