Device recall
Z-0263-2012: Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological…
FDA device recall · Class I · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0263-2012 |
|---|---|
| Recall event | 60155 |
| Product | Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on… |
| Product code | MHX |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 1, 2013 |
| 510(k) numbers | K093788 |
| FEI number | 2517967 |
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