Drug recall
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and…
FDA recall event 78100 · Class II · HILL-ROM MANUFACTURING, INC.
Key facts
| Event ID | 78100 |
|---|---|
| Recall numbers | Z-0192-2018 |
| Recalling firm | HILL-ROM MANUFACTURING, INC. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 15, 2017 |
| Report date | Dec 6, 2017 |
| Termination date | May 29, 2019 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2183816 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: