Device recall
Z-0014-04: Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
FDA device recall · Class II · GE Medical Systems Information Technologies
Key facts
| Recall number (Z-number) | Z-0014-04 |
|---|---|
| Recall event | 26278 |
| Product | Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130 |
| Recalling firm | GE Medical Systems Information Technologies |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2012 |
| FEI number | 1030184 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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