Device recall
Z-0927-2018: O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000…
FDA device recall · Class II · Medtronic Navigation, Inc.-Littleton
Key facts
| Recall number (Z-number) | Z-0927-2018 |
|---|---|
| Recall event | 79272 |
| Product | O-arm O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is… |
| Product code | OWB |
| Recalling firm | Medtronic Navigation, Inc.-Littleton |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2019 |
| 510(k) numbers | K151000 |
| FEI number | 3004785967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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