Device recall
Z-0997-2015: Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0997-2015 |
|---|---|
| Recall event | 69742 |
| Product | Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults. |
| Product code | LKD |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2015 |
| 510(k) numbers | K110474 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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