Device recall
Z-0760-2024: Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF…
FDA device recall · Class II · Getinge Usa Sales Inc
Key facts
| Recall number (Z-number) | Z-0760-2024 |
|---|---|
| Recall event | 93567 |
| Product | Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF… |
| Product code | FTD |
| Recalling firm | Getinge Usa Sales Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3013876692 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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