Device recall
Z-1104-2021: Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for…
FDA device recall · Class II · Draegar Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1104-2021 |
|---|---|
| Recall event | 87176 |
| Product | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. |
| Product code | MHX |
| Recalling firm | Draegar Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093788, K113798 |
| 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