Device recall
Z-0192-2018: Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue…
FDA device recall · Class II · HILL-ROM MANUFACTURING, INC.
Key facts
| Recall number (Z-number) | Z-0192-2018 |
|---|---|
| Recall event | 78100 |
| 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… |
| Product code | BYI |
| Recalling firm | HILL-ROM MANUFACTURING, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2019 |
| 510(k) numbers | K163378 |
| FEI number | 2183816 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database