Device recall
Z-2266-2018: CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The…
FDA device recall · Class II · Datex-Ohmeda, Inc.
Key facts
| Recall number (Z-number) | Z-2266-2018 |
|---|---|
| Recall event | 80173 |
| Product | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically… |
| Product code | CBK |
| Recalling firm | Datex-Ohmeda, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2021 |
| 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