Recall Z-0066-2014
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD · initiated September 18, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
Codes / lots: GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0066-2014
- Initiated
- September 18, 2013
- Posted by FDA
- October 24, 2013
- Terminated
- January 27, 2014
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- Quantity
- 29
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
- Recalling firm
- GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, Beijing