GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products
FDA device recall Z-0066-2014 · posted 2013-10-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
- Reason for recall
- GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated September 18,2013, to all affected customers to inform them of the issue and provide instructions for immediate mitigation of the issue. Customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions. Customers with questions were instructed to call 1-800-874-7378 option 8. For questions regarding this recall call 801-295-4952.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 29
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
- Date initiated
- 2013-09-18
- Date posted
- 2013-10-24
- Date terminated
- 2014-01-27
- Location
- Beijing, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME (K123603) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013-05-17 |