Monarch Airway Clearance System — Class II medical device recall Z-0192-2018
Terminated recall by HILL-ROM MANUFACTURING, INC., reported 2017-12-06, distributed nationwide. Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable ca
| Recall number | Z-0192-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HILL-ROM MANUFACTURING, INC., Saint Paul, MN, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-11-30 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2019-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 60 devices |
| Serial numbers | S082VM0092, S082VM0093, S082VM0095, S095VM0119, S095VM0124, S095VM0125, S114VM0152, S119VM0158, S119VM0160, S119VM0161, S119VM0162, S122VM0165, S122VM0166, S122VM0168, S122VM0170, S122VM0171, S122VM0172, S122VM0175, S122VM0176, S124VM0177, S124VM0178, S124VM0180, S124VM0181, S126VM0187, S126VM0193 and 35 more |
| Model numbers | 1000 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0192-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.