Device recall
Z-0766-2024: Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14…
FDA device recall · Class II · Getinge Usa Sales Inc
Key facts
| Recall number (Z-number) | Z-0766-2024 |
|---|---|
| Recall event | 93567 |
| Product | Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X10DF DUO… |
| Product code | FSY |
| Recalling firm | Getinge Usa Sales Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K040735 |
| 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