Recall Z-0071-2017— GE OEC Medical Systems, Inc

Name: FDA recall Z-0071-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-23

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-09-23, terminated 2017-04-24. It names one FDA 510(k) clearance: K123603. Product: OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC 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. The OEC Brivo is not indicated for interventional use.. Reason: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Terminated: 2017-04-24
Firm location: Salt Lake City, UT, United States

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

OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC 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. The OEC Brivo is not indicated for interventional use.

Reason for recall

GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.

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