Device recall
Z-0975-2019: Omega Systems These devices are intended to be used in the environment where…
FDA device recall · Class II · Draegar Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0975-2019 |
|---|---|
| Recall event | 82014 |
| Product | Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical… |
| Product code | MHX |
| Recalling firm | Draegar Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141756 |
| FEI number | 3005783425 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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