Device recall
Z-2738-2018: The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM…
FDA device recall · Class II · Datex-Ohmeda, Inc.
Key facts
| Recall number (Z-number) | Z-2738-2018 |
|---|---|
| Recall event | 80458 |
| Product | The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing… |
| Product code | CBK |
| Recalling firm | Datex-Ohmeda, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 22, 2019 |
| 510(k) numbers | K142679 |
| FEI number | 2183066 |
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