Device recall
Z-0764-2024: Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL…
FDA device recall · Class II · Getinge Usa Sales Inc
Key facts
| Recall number (Z-number) | Z-0764-2024 |
|---|---|
| Recall event | 93567 |
| Product | Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567502961C, AXL+5001 SF… |
| Product code | FSY |
| Recalling firm | Getinge Usa Sales Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030906 |
| FEI number | 3013876692 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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