Device recall
Z-0611-2024: Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X…
FDA device recall · Class II · ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Key facts
| Recall number (Z-number) | Z-0611-2024 |
|---|---|
| Recall event | 93463 |
| Product | Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules |
| Product code | FNL |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3007420694 |
At a glance
- None 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