Events

Recall of Monarch Airway Clearance System 1000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HILL-ROM MANUFACTURING, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78100
  • Event Risk Class
    Class 2
  • Event Number
    Z-0192-2018
  • Event Initiated Date
    2017-09-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158666
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Percussor, powered-electric - Product Code BYI
  • 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.

Device

Monarch Airway Clearance System 1000
  • Model / Serial
    Serial numbers S082VM0092, S122VM0171, S128VM0205, S151VM0242, S082VM0093, S122VM0172, S132VM0210, S151VM0243, S082VM0095, S122VM0175, S132VM0212, S152VM0251, S095VM0119, S122VM0176, S132VM0213, S157VM0257, S095VM0124, S124VM0177, S135VM0216, S157VM0261, S095VM0125, S124VM0178, S136VM0219, S158VM0264, S114VM0152, S124VM0180, S136VM0222, S158VM0266, S119VM0158, S124VM0181, S136VM0223, S158VM0267, S119VM0160, S126VM0187, S138VM0224, S158VM0268, S119VM0161, S126VM0193, S138VM0226, S158VM0271, S119VM0162, S126VM0198, S146VM0227, S158VM0273, S122VM0165, S126VM0199, S146VM0229, S159VM0276, S122VM0166, S128VM0202, S146VM0230, S160VM0279, S122VM0168, S128VM0203, S151VM0238, S167VM0289, S122VM0170, S128VM0204, S151VM0240, and S167VM0291.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    HILL-ROM MANUFACTURING, INC.

Manufacturer

HILL-ROM MANUFACTURING, INC.
  • Manufacturer Address
    HILL-ROM MANUFACTURING, INC., 1020 County Road F W, Saint Paul MN 55126-2910
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA