Device recall
Z-0071-2017: OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-0071-2017 |
|---|---|
| Recall event | 75330 |
| Product | OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical… |
| Product code | OXO |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2017 |
| 510(k) numbers | K123603 |
| FEI number | 1720753 |
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