Device recall
Z-0280-2019: O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT…
FDA device recall · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Recall number (Z-number) | Z-0280-2019 |
|---|---|
| Recall event | 81153 |
| Product | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D… |
| Product code | OXO |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2020 |
| 510(k) numbers | K092564 |
| FEI number | 3004785967 |
At a glance
- 1–9 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