Device recall
Z-2251-2012: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak)…
FDA device recall · Class I · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2251-2012 |
|---|---|
| Recall event | 62715 |
| Product | OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is… |
| Product code | LLZ |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 28, 2012 |
| 510(k) numbers | K960330, K981998, K982994, K983529, K990919, K994270 |
| FEI number | 1720753 |
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