Device recall
Z-0258-2018: Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician…
FDA device recall · Class II · Orthoscan, Inc.
Key facts
| Recall number (Z-number) | Z-0258-2018 |
|---|---|
| Recall event | 78784 |
| Product | Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures. |
| Product code | OXO |
| Recalling firm | Orthoscan, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 21, 2021 |
| 510(k) numbers | K051754 |
| FEI number | 3005254598 |
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