FDA Medical Device Recalls (openFDA)
HILL-ROM MANUFACTURING, INC.: 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 number
- Z-0192-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-09-15
- Posted
- not on file
- Terminated
- 2019-05-29
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K163378"]
- PMA numbers
- not on file
- Product code
- BYI
- Firm FEI
- 2183816
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28