Device recall
Z-0008-2015: Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd…
FDA device recall · Class I · Respironics California Inc
Key facts
| Recall number (Z-number) | Z-0008-2015 |
|---|---|
| Recall event | 69313 |
| Product | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for… |
| Product code | CBK |
| Recalling firm | Respironics California Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 28, 2016 |
| 510(k) numbers | K001208, K023350, K034040, 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