BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0192-2018 · Initiated September 15, 2017

    Recall

    Recall Number
    Z-0192-2018
    Event Number
    78100
    Firm
    HILL-ROM MANUFACTURING, INC.
    FEI Number
    2183816
    Product Code
    BYI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2017
    Terminated
    May 29, 2019
    Address
    1020 County Road F W, Saint Paul, MN, 55126-2910

    Description

    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.

    Reason

    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.

    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.

    Distribution

    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.

    Quantity

    60 devices