Device recall
Z-0974-2019: Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta…
FDA device recall · Class II · Draegar Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0974-2019 |
|---|---|
| Recall event | 82014 |
| Product | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and… |
| Product code | MHX |
| Recalling firm | Draegar Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152407 |
| 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