Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monarch Airway Clearance System Recalled by HILL-ROM MANUFACTURING, INC. Due to Monarch Electromagnetic Interference (EMI) may disrupt the operation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact HILL-ROM MANUFACTURING, INC. directly.
Affected Products
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.
Quantity: 60 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About HILL-ROM MANUFACTURING, INC.
HILL-ROM MANUFACTURING, INC. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report