Device recall
Z-2613-2023: Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model…
FDA device recall · Class II · GE Medical Systems Information Technologies Inc
Key facts
| Recall number (Z-number) | Z-2613-2023 |
|---|---|
| Recall event | 92903 |
| Product | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. |
| Product code | DQK |
| Recalling firm | GE Medical Systems Information Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213972 |
| FEI number | 3012359877 |
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