Device recall
Z-1134-2012: Philips IntelliVue Patient Monitors: The monitor is intended to be used for…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1134-2012 |
|---|---|
| Recall event | 61127 |
| Product | Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals… |
| Product code | MHX |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2017 |
| 510(k) numbers | K110622 |
| FEI number | 1218950 |
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