Device recall
Z-1995-2009: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05…
FDA device recall · Class II · GE Medical Systems Information Tecnology
Key facts
| Recall number (Z-number) | Z-1995-2009 |
|---|---|
| Recall event | 51278 |
| Product | Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and… |
| Product code | MLD |
| Recalling firm | GE Medical Systems Information Tecnology |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2012 |
| 510(k) numbers | K022740 |
| FEI number | 3005860720 |
At a glance
- 1–9 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