Device recall
Z-0184-06: Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The…
FDA device recall · Class II · Pulmonetic Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0184-06 |
|---|---|
| Recall event | 33974 |
| Product | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in… |
| Product code | CBK |
| Recalling firm | Pulmonetic Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2007 |
| 510(k) numbers | K002881, K010608, K981371, K984056 |
| FEI number | 3002617992 |
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