Device recall
Z-2258-2024: Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology…
FDA device recall · Class II · GE Medical Systems Information Technologies Inc
Key facts
| Recall number (Z-number) | Z-2258-2024 |
|---|---|
| Recall event | 94717 |
| Product | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare part #5875569 (Assy CLABIII AMP 128CH 100-240V 50-60HZ). |
| Product code | DQK |
| Recalling firm | GE Medical Systems Information Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K050093 |
| 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