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U.S. Department of Health and Human Services

Class 2 Device Recall GE Brivo OEC

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 Class 2 Recall
GE Brivo OEC
see related information
Date Posted October 24, 2013
Recall Status1 Terminated on January 27, 2014
Recall Number Z-0066-2014
Recall Event ID 66341
Premarket Notification
510(K) Number
K123603 
Product Classification Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Code OXO
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.
Code Information GE Brivo OEC715: Serial Numbers B2S13001 ~ B2S13010. GE Brivo OEC785: Serial Numbers B3S13005 ~ B3S13008. GE Brivo OEC865: Serial Numbers B4S13001 ~ B4S13015
Recalling Firm/
Manufacturer
GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing
For Additional Information Contact Deena Pease
801-295-4952
Manufacturer 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 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 29
Distribution Worldwide Distribution - USA (nationwide) and Internationally to China, India, Japan, Malaysia, Australia, Ireland, France, Germany, Spain, Hungary, Belgium, and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
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