HILL-ROM MANUFACTURING, INC. recalls Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (h…

Recall date

September 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0192-2018

FDA classification

Class II

Brand / firm

HILL-ROM MANUFACTURING, INC.

Sold / distributed

USA (nationwide) Distribution to the states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, VA, WA, WI, and WV. Internationally to Canada. There was no military/government distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.