Recall Z-0066-2014— GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD

Name: FDA recall Z-0066-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-18

Class II · Terminated

Class II FDA medical device recall by GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD, initiated 2013-09-18, terminated 2014-01-27. It names one FDA 510(k) clearance: K123603. 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.. Reason: 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..

Recalling firm: GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Terminated: 2014-01-27
Firm location: Beijing, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K123603 — OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2013-05-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.