Device recall
Z-3080-2011: Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23…
FDA device recall · Class II · Impact Instrumentation, Inc.
Key facts
| Recall number (Z-number) | Z-3080-2011 |
|---|---|
| Recall event | 59400 |
| Product | Model 754/754M Disposable MRI Ventilator Circuit Impact Instrumentation Inc., 23 Fairfield Place, West Caldwell, NJ 07006. Accessory for 700 Series 754/754m Ventilators during MRI examinations |
| Product code | cbk |
| Recalling firm | Impact Instrumentation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2013 |
| FEI number | 1220908 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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