Device recall
Z-0066-2014: GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus…
FDA device recall · Class II · GE Healthcare Beijing, Hangwei Medical Systems, Co. LTD
Key facts
| Recall number (Z-number) | Z-0066-2014 |
|---|---|
| Recall event | 66341 |
| Product | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC 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 Healthcare Beijing , Hangwei Medical Systems, Co. LTD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2014 |
| 510(k) numbers | K123603 |
| FEI number | 3002175190 |
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