Device recall
Z-0928-2018: O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE…
FDA device recall · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Recall number (Z-number) | Z-0928-2018 |
|---|---|
| Recall event | 79275 |
| Product | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS… |
| Product code | OXO |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2019 |
| 510(k) numbers | K092564 |
| FEI number | 3004785967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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