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 Z-0192-2018 · Posted None
Recalling FirmHILL-ROM MANUFACTURING, INC.
Recall StatusTerminated
Product CodeBYI
Date Initiated2017-09-15
Date Terminated2019-05-29
Product Quantity60 devices
Reason for Recall
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.
Firm Action
Phone calls were initiated September 15, 2017, to the customers, who are users.
The expanded recall was initiated by letter dated November 13, 2017,via FedEx with delivery confirmation to both the users identified in the September notification and to the users who later received the recalled product. (Two local consignees will be provided the letter in person and one consignee will be sent the letter via USPS.) For further questions, please call (800) 426-4224.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.