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Terminated

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.

FDA Recall Z-0071-2017 · Posted 2016-10-11

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2016-09-23
Date Terminated2017-04-24
Product Quantity148 total

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.

Firm Action

GE Healthcare sent an Urgent Medical Device Correction letter dated September 23, 2016 to customers. The letter informed customers of the affected product, safety issue, and safety instructions for immediate mitigation of the issue. GE Healthcare will correct all affected products at no cost to customers. A GE Healthcare representative will the customers to arrange for the correction. Please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123603OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIMEGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2013-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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