Device recall
Z-0485-2015: Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000…
FDA device recall · Class II · Respironics California Inc
Key facts
| Recall number (Z-number) | Z-0485-2015 |
|---|---|
| Recall event | 69728 |
| Product | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult… |
| Product code | CBK |
| Recalling firm | Respironics California Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2016 |
| 510(k) numbers | K001208, K023350, K034040, K041412, K981072 |
| FEI number | 2518422 |
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