Z-0192-2018Class II

Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and...

Name: Z-0192-2018 Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and...
Creator: Hill-Rom Manufacturing, Inc.
Published: 2017-09-15
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2017-09-15 / Terminated

FDA source

HILL-ROM MANUFACTURING, INC. began a recall of Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on... on 2017-09-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0192-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2017-11-30
Terminated: 2019-05-29
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: 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.
Product code: BYI Percussor, Powered-Electric
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.
FDA root cause: Other
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.
Quantity in commerce: 60 devices
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0192-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0192-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-30

Product code BYI

K163378Class IIMonarch Airway Clearance SystemHill-Rom Services Pte, Ltd. / cleared 2017-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)